(197 days)
No
The device description and performance studies focus on the physical properties and functionality of an enteral extension set and adapter, with no mention of AI or ML.
No
Explanation: The device is an enteral extension set used for providing nutrition. It is a conduit for feeding, not a device that provides therapy for a disease or condition.
No
The device is an enteral extension set designed to deliver nutrition and medication, not to diagnose medical conditions or diseases.
No
The device description clearly details physical components like flexible tubing, connectors, a tethered cap, and a clamp, indicating it is a hardware medical device. The performance studies also focus on physical properties and testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The BD UniVia™ RightFit enteral extension set and transition adapter are used to deliver nutrition and medication directly into the gastrointestinal tract via a feeding tube. They are part of a system for administering substances into the body, not for analyzing substances from the body.
- Intended Use: The intended use clearly states providing nutrition via nasal or oral gastric tube placements. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they facilitate the connection and flow of substances for feeding. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies listed are related to the physical integrity, flow characteristics, and biocompatibility of the device for its intended use in enteral feeding. There are no studies related to diagnostic accuracy or analysis of biological samples.
Therefore, the BD UniVia™ RightFit enteral extension set and transition adapter are medical devices used for enteral feeding, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.
BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniViaTM RightFit enteral systems.
Product codes (comma separated list FDA assigned to the subject device)
PIF, PIO
Device Description
Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:
- Standard enteral extension sets, with a variation in tube length and diameter
- Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length
Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines.
The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:
- Enteral female to enteral female
- Enteral male to enteral male
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric and adult 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)
Device evaluation consisted of in vitro testing performed pursuant to MPS Medical's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following testing was performed to support the determination of substantial equivalence:
- Visual Insertion and removal force Dimensions Leakage Stress cracking Resistance to separation Resistance to overriding Disconnection by unscrewing Kink resistance Tensile force Flow rate Human factors
Biocompatibility testing was conducted in accordance with ISO 10993-1.
Sterilization testing was conducted in accordance with ISO 11135 to ensure a sterility assurance level (SAL) of 10-6.
Shipping and distribution testing was conducted in accordance with ISO 11607-1.
Shelf life testing was performed.
The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate device.
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2020
MPS Medical, Inc. Paul Gasser Medical Device RA/OA Consultant 830 Challenger Street, Suite 200 Brea, CA 92821
Re: K200082
Trade/Device Name: BD Univia RightFit Enteral Extension Sets and Transitional Adapters Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, PIO Dated: June 30, 2020 Received: July 1, 2020
Dear Paul Gasser:
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.
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
1
1 CFR Part 207) labeling (21 CFR Part
Page
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
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) K200082
Device Name
BD UniVia™ RightFit Extension Sets and Transitional Adapters
Indications for Use (Describe)
BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.
BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniViaTM RightFit enteral systems.
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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3
Traditional 510(k) Summary
| Submitter: | MPS Medical, Inc.
830 Challenger, Suite 200
Brea, CA 92821
USA |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Susan Ginsberg
Director, R&D
MPS Medical, Inc.
Telephone: 844-641-3814
E-mail: sginsberg@mpsmedical-inc.com |
| Date Summary Prepared: | January 15, 2020 |
| Device Trade Name: | BD UniVia™ RightFit Extension Sets and Transitional Adaptors |
| Common Name: | Enteral Extension Sets |
| Classification Name: | Gastrointestinal tube and accessories (21 CFR 876.5980) |
| Regulatory Class: | Class II |
| Product Code: | PIF, PIO |
| Predicate Device: | VR Medical Feeding Tube
(510(k) K180236) |
| Reference Device: | Neomed Enteral Extension Set
(510(k) K100288) |
Device Description:
Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:
- Standard enteral extension sets, with a variation in tube length and diameter
- . Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length
Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines.
4
The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:
- Enteral female to enteral female ●
- Enteral male to enteral male
Indications for Use:
BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.
BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.
Statement of Equivalence:
The subject device and the predicate share a similar intended use and have similar technological characteristics.
Key differences between the subject and predicate devices are reflected in the following table.
| Characteristic | Predicate Device
VR Medical Enteral Feeding | Subject Device
MPS Medical Enteral Extension |
|------------------------|------------------------------------------------|-------------------------------------------------|
| | Extension Set (EFES) | Set and Transitional Adapters |
| Enteral Extension Sets | | |
| Length (inches) | 22 - 60 | 8 - 60 |
| ID/OD (mm) | Unknown | 0.89/2.4, 2.1/3.5, 3.0/4.1 |
| Connectors | Male/female per ISO 80369-3 | Same |
| Transitional Adapters | | |
| Length (inches) | None | 1.9 - 2.2 |
| ID/OD (mm) | None | 2.1/3.5 |
| Connectors | None | Male and female connectors
per ISO 80369-3 |
The BD UniVia™ RightFit enteral extension sets and transitional adapters are substantially equivalent to the predicate device.
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510(k) K 200082 Page 3 of 3
Summary of Non-Clinical Performance Data:
Device evaluation consisted of in vitro testing performed pursuant to MPS Medical's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following testing was performed to support the determination of substantial equivalence:
- Visual Insertion and removal force Dimensions Leakage Stress cracking Resistance to separation Resistance to overriding Disconnection by unscrewing Kink resistance Tensile force Flow rate Human factors
Biocompatibility Testing:
Biocompatibility testing was conducted in accordance with ISO 10993-1.
Sterilization Testing:
Sterilization testing was conducted in accordance with ISO 11135 to ensure a sterility assurance level (SAL) of 10-6.
Transportation and Shelf Life Testing:
Shipping and distribution testing was conducted in accordance with ISO 11607-1.
Shelf life testing was performed.
The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate device.
Summary of Pre-Clinical and Clinical Data:
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.
Summarv:
Based on the intended use and in vitro performance information provided in this premarket notification, the BD UniVia™ RightFit Extension Sets and Transitional Adaptors are substantially equivalent to the predicate device.