(88 days)
No
The device description and performance studies focus on the mechanical and material properties of a feeding tube and its accessories. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
Explanation: The device is a feeding tube indicated for enteral feeding, medication administration, or decompression, which are all therapeutic interventions for patients requiring nutritional or medicinal support.
No
The device description and intended use clearly state that this is a feeding tube and associated accessories for enteral feeding, medication administration, or decompression. It is a delivery device, not one designed to diagnose a condition or disease.
No
The device description clearly details physical components made of silicone and other materials, including a hub, shaft, balloon, and various connectors and accessories. The performance studies focus on bench testing of these physical properties and biocompatibility, not software validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering enteral feeding, medication, or decompression through an established gastrointestinal stoma tract. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a feeding tube and associated components designed for insertion into the body to deliver substances. It does not perform any tests on biological samples outside of the body to diagnose a condition.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the device (e.g., resistance to migration, leak testing, tensile strength, biocompatibility) and its compatibility with other enteral feeding systems. There are no studies related to diagnostic accuracy or performance on biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
In summary, the device is a medical device used for delivering substances into the body, which falls under the category of therapeutic or supportive devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.
The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatic patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.
Product codes
PIF
Device Description
The proposed devices are listed below in Table 5.5-1 and are described following the table.
| Device Part
| Number | Device Brand Name | Hereafter Referred to As |
|---|---|---|
| 50-0508 | Kangaroo™ Skin Level Device | Kangaroo™ SLD |
| 70-0079 | Kangaroo™ Skin Level Balloon Gastrostomy Kit | Kangaroo™ SLD Kit |
| 20-1724 | Kangaroo™ 24" Continuous Feed Extension Set | Continuous ES |
| 20-1725 | Kangaroo™ 12" Bolus Feed Extension Set | Bolus ES |
| 50-0509 | Kangaroo™ Bolus Feed Set with ENFit® Connection (10 pack of Bolus Feed Set) | FSK - Bolus |
| 50-0510 | Kangaroo™ Continuous Feed Set with ENFit® Connection (10 pack of Continuous Feed Set) | FSK - Continuous |
Table 5.5-1 - Proposed Devices
The Kangaroo ™ Skin Level Balloon Gastrostomy Kit will be comprised of one Kangaroo™ Skin Level Device and one of each of the feed sets. The feed sets, continuous and bolus, are also available in Feed Set Kits packaged individually and then boxed as a 10-pack.
The Kangaroo™ SLD is constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. The tip of the shaft is filled with radiopaque barium RTV. At the distal end, a silicone subsumed tip balloon is reverse bonded to the shaft using a silicone RTV. This subsumed tip balloon accomplishes patient comfort by not exposing the tip of the shaft to the patient as well as being in line with the shaft. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present. Accessories for the Kangaroo™ SLD include two feed extension set confiqurations (ENFit bolus and continuous), an inflation syringe, a feeding syringe (ENFit), and gauzes.
The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the feed set valve connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.
The device is available in the configurations per determined market needs shown below in Table 5.5-2.
The feed extension sets have a valve connector end that inserts into the Kangaroo™ SLD reflux valve. For these ENFit Feed Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with nonenteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. Finally, both the Kangaroo™ Skin Level Device and the Kangaroo™ Feed Sets are compatible with competitor devices currently on the market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal stoma tract, stomach
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Based on detailed analysis of the proposed devices as compared to the predicate device (documented design equivalency analysis) and considering previous testing on materials in both the predicate and reference devices, it was determined what new Verification and Validation Testing was required for the proposed devices and what testing can be legitimately leveraged from the predicate and reference devices. Based on the combination of new and leveraged testing, it was found the proposed devices are in compliance with design and performance requirements according to ISO 80369-3:2016/AMD1:2019 Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications, EN1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing (with additional support from ISO 20695:2020 Enteral feeding systems - design and testing), and biocompatibility requirements per ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
The following testing was conducted on proposed devices or leveraged from the predicate device or reference device (leveraging based on design equivalency) to support substantial equivalence of the proposed devices:
Biocompatibility
- Per prior assessment consistent with ISO 10993-1:2018, confirming cytotoxicity, sensitization and irritation tests completed on predicate device and deemed applicable to proposed device per design equivalency assessment
Sterilization
- Based on sterilization adoption assessment and design equivalency assessment, EO residuals testing on predicate device deemed applicable to proposed device
Performance Testing Bench (combined new and leveraged)
- Resistance to device migration (hub or balloon)
- Enteral feeding devices (with a retention balloon) testing per ASTM F2528-. 06(2014)
- Tensile testing per EN 1615:2000 and EN 1618:1997
- Leak testing per EN1615:2000, EN 1618:1997 and ISO 20695:2020
- Valve connector insertion/removal force testing per ISO 20695:2020
- Low profile device-valve connector torque testing
- Feed/extension set pinch clamp testing (able to stop fluid flow)
- Testing for resistance to expected chemical exposure
- Distribution simulation testing
- Design validation testing per simulated use conditions, including blenderized diet
Results from all the above tests met the acceptance criteria for each test.
Animal Tests: Animal tests were not required to demonstrate the performance of the proposed devices. Product functionality has been adequately assessed by the non-clinical tests discussed in 5.8.1.
Clinical Tests: Clinical tests were not required to demonstrate the performance of the proposed devices. Product functionality has been adequately assessed by the non-clinical tests discussed in 5.8.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
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October 6, 2023
Xeridiem Medical Devices, A Spectrum Plastics Group Company Mr. Steve Murray Regulatory Affairs Specialist 4700 S. Overland Dr. Tucson, AZ 85714
Re: K232046
Trade/Device Name: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: July 5, 2023 Received: July 10, 2023
Dear Steve Murray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232046
Device Name Kangaroo Skin Level Balloon Gastrostomy Kit Kangaroo Bolus Feed Set with ENFIT Connection Kangaroo Continuous Feed Set with ENFIT Connection
Indications for Use (Describe)
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.
The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatic patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.0 510(k) SUMMARY
5.1 Submitter Information
| Date Prepared: | June 30, 2023 |
|---|---|
| 510(k) Submitter: | Xeridiem Medical Devices, |
| A Spectrum Plastics Group Company | |
| 4700 S. Overland Dr. | |
| Tucson, AZ 85714 | |
| Contact Person: | Steve Murray, Regulatory Affairs Special |
| Contact Person: | Steve Murray, Regulatory Affairs Specialist
(520) 882-7794 ext. 178
steven.murray@spectrumplastics.com |
| ----------------- | -------------------------------------------------------------------------------------------------------------- |
|---|
5.2 Device Information
| Trade Name: | Kangaroo™ Skin Level Balloon Gastrostomy Kit |
|---|---|
| Kangaroo™ Bolus Feed Set with ENFit® Connection | |
| Kangaroo™ Continuous Feed Set with ENFit® Connection |
| Common Name: | Low Profile Gastrostomy Tube |
|---|---|
| Classification Name: | Gastrointestinal tube and accessories |
| (21 CFR 876.5980, Product Code PIF) | |
| Classification Panel: | Gastroenterology/Urology |
Predicate Device Information 5.3
| Trade Name: | Entuit® LP Gastrostomy BR Balloon Retention
Feeding Tube Kit with ENFit® Connection |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name: | Low Profile Gastrostomy Tube |
| Classification Name: | Gastrointestinal tube and accessories
(21 CFR 876.5980, Product Code PIF) |
| 510(k) Number: | K180708 |
Reference Device Information 5.4
| Trade Name: | EndoVive™ 3s Low Profile Balloon Kit*
EndoVive™ 3s Bolus Extension Sets
EndoVive™ 3s Continuous Extension Sets
EndoVive™ 3s Medication Extension Set |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Gastrostomy Tube |
| Classification Name: | Gastrointestinal tube and accessories
(21 CFR 876.5980, Product Codes PIF, PIO) |
| 510(k) Number: | K142297 |
4
- Low profile device from the Low Profile Balloon Kit is the only part of the cleared device beinq used for reference considerations in technological characteristics.
5.5 Device Description
The proposed devices are listed below in Table 5.5-1 and are described following the table.
| Device Part
| Number | Device Brand Name | Hereafter Referred to As |
|---|---|---|
| 50-0508 | Kangaroo™ Skin Level Device | Kangaroo™ SLD |
| 70-0079 | Kangaroo™ Skin Level Balloon Gastrostomy Kit | Kangaroo™ SLD Kit |
| 20-1724 | Kangaroo™ 24" Continuous Feed Extension Set | Continuous ES |
| 20-1725 | Kangaroo™ 12" Bolus Feed Extension Set | Bolus ES |
| 50-0509 | Kangaroo™ Bolus Feed Set with ENFit® Connection (10 pack of Bolus Feed Set) | FSK - Bolus |
| 50-0510 | Kangaroo™ Continuous Feed Set with ENFit® Connection (10 pack of Continuous Feed Set) | FSK - Continuous |
Table 5.5-1 - Proposed Devices
The Kangaroo ™ Skin Level Balloon Gastrostomy Kit will be comprised of one Kangaroo™ Skin Level Device and one of each of the feed sets. The feed sets, continuous and bolus, are also available in Feed Set Kits packaged individually and then boxed as a 10-pack.
The Kangaroo™ SLD is constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. The tip of the shaft is filled with radiopaque barium RTV. At the distal end, a silicone subsumed tip balloon is reverse bonded to the shaft using a silicone RTV. This subsumed tip balloon accomplishes patient comfort by not exposing the tip of the shaft to the patient as well as being in line with the shaft. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque
5
barium stripe present. Accessories for the Kangaroo™ SLD include two feed extension set confiqurations (ENFit bolus and continuous), an inflation syringe, a feeding syringe (ENFit), and gauzes.
The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the feed set valve connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.
The device is available in the configurations per determined market needs shown below in Table 5.5-2.
| FR | LENGTH (CM) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SIZE | 0.8 - | 1.0 1.2 | 1.5 | 1.7 | 2.0 | 2.3 | 2.5 | 2.7 3.0 | 3.5 | 4.0 4.5 | 5.0 | |||
| 12 | イ | > | > | " > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > | > | " √ √ . | > | > | = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = | > | > | > | ||
| 14 | イ | イ | > | > | > | > | > | V / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / | > = | > | > | イ | ||
| 16 | > | > | > | イ | > | > | > | : | V . | > | > | > | > | > |
| 18 | > | イ | > | 「 ノ ・ | > | > | > | >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> | >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> | > | イ | " √ . | > | > |
| 20 | > | イ | > | > | > | >> | " √ . | > | " √ . | > = | VI | > | > | |
| 22 | > | イ | > | > | > | > | > | > | V I | > | > | > | > | イ |
| 24 | > | > | > | > | > | ! ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | > | イ | > | > | V | > | ! ノ ・ |
| Table 5.5-2 – Kangaroo™ SLD Configurations (Length [cm] for Each FR Size) | |
|---|---|
| FR | LENGTH (CM) |
The feed extension sets have a valve connector end that inserts into the Kangaroo™ SLD reflux valve. For these ENFit Feed Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with nonenteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. Finally, both the Kangaroo™ Skin Level Device and the Kangaroo™ Feed Sets are compatible with competitor devices currently on the market.
5.6 Indications for Use
5.6.1 KangarooTM Skin Level Balloon Gastrostomy Kit
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration, or decompression through an established gastrointestinal stoma tract.
The Kanqaroo™ Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a Kangaroo™ Skin Level Device.
6
5.6.2 Kangaroo™ Bolus Feed Set with ENFit® Connection and Kangaroo™ Continuous Feed Set with ENFit® Connection (10-Pack Kits)
The Kangaroo™ Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a Kangaroo™ Skin Level Device.
5.7 Technological Characteristics
The proposed device, as shown in Table 5.7 below with specific similarities and differences, have the same or very similar technological characteristics as the predicate device. The intended uses of the proposed device and predicate device are the same and there are no significant differences noted in the table below that would affect the performance of the proposed device as compared to the predicate device. The reference device is used as the comparison for certain balloon characteristics (see Table 5.7a below the main table).
| | PREDICATE DEVICE
(K180708) | PROPOSED DEVICE |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | Entuit® LP Gastrostomy BR Balloon
Retention Feeding Tube Kit with
ENFit® Connection | Kangaroo™ Skin Level Device Kit
with Feed Sets |
| FDA Class | Class II | Same as K180708 |
| FDA Product Code | PIF (for ENFit-compatible) | Same as K180708 |
| FDA Regulation | 876.5980 - Tubes, gastrointestinal
(and accessories) | Same as K180708 |
| 510(k) Number | K180708 | TBD |
| Indications for Use | The feeding tube is indicated for
use in percutaneous placement of
an enteral feeding tube in adult and
pediatric patients that require
enteral feeding, medication
administration or decompression
through an established
gastrointestinal stoma tract. | Same as K180708 |
| User Population | Adult and Pediatric | Same as K180708 |
| Operating Principle | Device tip enters through the stoma
tract and into the stomach, then the
device is secured in place by
inflating the retention balloon. Once
secured in place, the appropriate
extension set is connected to the
device and it then serves as a
channel for administering nutrients
and medication into the stomach
and for gastric decompression. | Same as K180708 |
| Table 5.7 - Device Comparison Table (Predicate Device) | |||
|---|---|---|---|
| PREDICATE DEVICE | |||
| (K180708) | PROPOSED DEVICE | ||
| Entuit® LP Gastrostomy BR Balloon | |||
| Retention Feeding Tube Kit with | |||
| ENFit® Connection | Kangaroo™ Skin Level Device Kit | ||
| with Feed Sets | |||
| Sterile | Yes (ETO) for pouch-sealed low | ||
| profile device | Same as K180708 | ||
| Shaft | Silicone 65D | Silicone 65D (same as K180708); | |
| adds four additional functional | |||
| lengths: 1.2cm, 1.7cm, 2.3cm, | |||
| 2.7cm | |||
| Balloon | Silicone 24D | Silicone 24D (with reverse bonding | |
| for subsumed device tip)* | |||
| Balloon Inflation Rating | 12-16 FR tubing size: 5-7 mL | ||
| 18-24 FR tubing size: 5-10 mL | 12 FR tubing size: 4 mL* | ||
| 14 FR tubing size: 4.5 mL* | |||
| 16 FR tubing size: 5 mL* | |||
| 18 FR tubing size: 6 mL* | |||
| 20 FR tubing size: 7 mL* | |||
| 22 FR tubing size: 8 mL* | |||
| 24 FR tubing size: 10 mL* | |||
| Reflux Valve | Silicone cross-slit valve | Silicone cross-slit valve (with | |
| silicone back-up seal) | |||
| Radiopaque Marker | Barium sulfate | Same as K180708 | |
| Balloon Inflation Valve | Thermoplastic housing with silicone | ||
| valve | Same as K180708 | ||
| Inflation Valve Port | Port on Silicone 60D hub which | ||
| houses inflation valve | Same as K180708 | ||
| Connectors (Feed | |||
| Extension Sets) | Valve Connector - Polycarbonate, | ||
| straight (bolus) or right angle | |||
| (continuous) | Same as K180708 | ||
| Pinch Clamps (Feed | |||
| Extension Sets) | Feeding Connector – Nylon (ENFit) | ||
| Both Bolus and Continuous ES - | |||
| print "Not for IV Use" symbol and | |||
| "For Enteral Use Only" warning on | |||
| pinch clamp; | |||
| Bolus ES - 6.8 mm OD | |||
| polypropylene pinch clamp | |||
| Continuous ES – 3.0 mm OD | |||
| polypropylene pinch clamp | Same as K180708 | ||
| Low Profile Kit | |||
| Contents | Inflation syringe, feeding syringe, | ||
| gauze, Bolus Extension Set, | |||
| Continuous Extension Set | Same as K180708 | ||
| Replacement Feed | |||
| Extension Kit Contents | 1 each Bolus Extension Set and | ||
| Continuous Extension Set | 10 each Bolus Feed Extension Sets | ||
| or 10 each Continuous Feed | |||
| Extension Sets | |||
| Packaging System/ | |||
| Materials | Tyvek Pouch (only with LPK), | ||
| Polybag, IFU, Corrugate Case & | |||
| Shipper | Same as K180708 | ||
| Competitor Device | |||
| Compatibility | No | Yes - for select competitor devices | |
| (competitor ES with Kangaroo SLD; | |||
| competitor LP device with | |||
| Kangaroo Feed Sets) |
7
8
*The Reference Device comparison in Table 5.7a supports these balloon characteristics.
| Table 5.7a - Device Comparison Table (Reference Device) | ||
|---|---|---|
| REFERENCE DEVICE | ||
| (K142297) | PROPOSED DEVICE | |
| EndoViveTM 3s Low Profile | ||
| Balloon Kit | KangarooTM Skin Level Device | |
| Kit with Feed Sets | ||
| Indications for Use | ||
| (applicable to low profile | ||
| device) | The EndoVive 3S Low Profile | |
| Balloon is indicated for use in | ||
| adult and pediatric patients who | ||
| require long term feeding, are | ||
| unable to tolerate oral feeding, | ||
| are at low risk for aspiration or | ||
| require gastric decompression | ||
| and/or medication delivery | ||
| directly into the stomach. | The feeding tube is indicated for | |
| use in percutaneous placement | ||
| of an enteral feeding tube in | ||
| adult and pediatric patients that | ||
| require enteral feeding, | ||
| medication administration or | ||
| decompression through an | ||
| established gastrointestinal | ||
| stoma tract. | ||
| Balloon | Silicone 24D (with reverse | |
| bonding for subsumed device | ||
| tip) | Same as K142297 | |
| Balloon Inflation Rating | 12 FR tubing size: 4 mL | |
| 14 FR tubing size: 4.5 mL | ||
| 16 FR tubing size: 5 mL | ||
| 18 FR tubing size: 6 mL | ||
| 20 FR tubing size: 7 mL | ||
| 22 FR tubing size: 8 mL | ||
| 24 FR tubing size: 10 mL | Same as K142297 |
As can be seen from the above tables, the changes are limited in scope and many characteristics are unchanged from the predicate device. The limited differences are as follows:
- . Addition of four additional functional lengths on the Skin Level Device (low profile gastrostomy tube) only offers additional options but does not impact functionality of the device;
- . Balloon is reverse bonded to create a subsumed device tip for enhanced patient comfort while retaining equivalent performance in retention;
- . The balloon inflation volume rating difference is due to the reverse bonded balloon process; the balloon is reversed and trimmed, resulting in less surface area of the balloon; the balloon is then positioned over the shaft, crating a subsumed tip when inflated; this process results in enhanced patient comfort but a decrease in inflation volume for most FR sizes; however, performance testing indicates retention requirements are met;
- . The updated reflux valve design (cross-slit valve with silicone back-up seal) performs the same function as the predicate device's reflux valve and is shown to be equivalent or better based on performance testing;
- The change from providing replacement feed extension sets in a pack of 1 each ● bolus/continuous to 10-pack of either bolus or continuous simply provides
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convenient options for replacing the type set a specific user needs and has no impact on safety or effectiveness;
- Compatibility of the Kangaroo™ devices with select competitor devices offers . more flexibility to the end user and has been verified through performance testing.
Any differences noted above do not raise new or different questions of safety or effectiveness as compared to the predicate device. The proposed device is deemed substantially equivalent.
5.8 Performance Data
5.8.1 Non-Clinical Tests
Based on detailed analysis of the proposed devices as compared to the predicate device (documented design equivalency analysis) and considering previous testing on materials in both the predicate and reference devices, it was determined what new Verification and Validation Testing was required for the proposed devices and what testing can be legitimately leveraged from the predicate and reference devices. Based on the combination of new and leveraged testing, it was found the proposed devices are in compliance with design and performance requirements according to ISO 80369-3:2016/AMD1:2019 Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications, EN1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing (with additional support from ISO 20695:2020 Enteral feeding systems - design and testing), and biocompatibility requirements per ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
The following testing was conducted on proposed devices or leveraged from the predicate device or reference device (leveraging based on design equivalency) to support substantial equivalence of the proposed devices:
Biocompatibility
-
Per prior assessment consistent with ISO 10993-1:2018, confirming cytotoxicity, ● sensitization and irritation tests completed on predicate device and deemed applicable to proposed device per design equivalency assessment
Sterilization -
Based on sterilization adoption assessment and design equivalency assessment, ● EO residuals testing on predicate device deemed applicable to proposed device
-
Performance Testing Bench (combined new and leveraged)
- Resistance to device migration (hub or balloon) ●
- Enteral feeding devices (with a retention balloon) testing per ASTM F2528-. 06(2014)
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- Tensile testing per EN 1615:2000 and EN 1618:1997 ●
- Leak testing per EN1615:2000, EN 1618:1997 and ISO 20695:2020 ●
- . Valve connector insertion/removal force testing per ISO 20695:2020
- Low profile device-valve connector torque testing
- Feed/extension set pinch clamp testing (able to stop fluid flow) ●
- Testing for resistance to expected chemical exposure .
- Distribution simulation testing
- Design validation testing per simulated use conditions, including blenderized diet ●
Results from all the above tests met the acceptance criteria for each test.
5.8.2 Animal Tests
Animal tests were not required to demonstrate the performance of the proposed devices. Product functionality has been adequately assessed by the non-clinical tests discussed in 5.8.1.
5.8.3 Clinical Tests
Clinical tests were not required to demonstrate the performance of the proposed devices. Product functionality has been adequately assessed by the non-clinical tests discussed in 5.8.1.
5.9 Conclusion
The conclusions drawn from the device comparison for technological characteristics and results of the non-clinical testing demonstrate that the proposed devices in the Kangaroo™ device family are as safe, effective, and perform as well or better than the legally marketed predicate device identified in 5.3, and/or the legally marketed reference device identified in 5.4.
(End of Section)