(103 days)
Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
The Enteral Feeding Sets have four models, Enteral Feeding Pump bag Set, Enteral Feeding Pump EnPlus spike Set, Enteral Feeding Gravity bag Set, Enteral Feeding Gravity EnPlus spike Set. The Enteral Feeding Pump bag Set and Enteral Feeding Gravity bag Set both have a structure of a formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. Enteral Feeding Pump EnPlus spike Set and Enteral Feeding Gravity EnPlus spike Set feature a piercing spike (with or without screw cap) used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
The provided document is a 510(k) Premarket Notification from the FDA for "Enteral Feeding Sets." It describes the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.
However, the document does not contain any information about a study that proves the device meets the acceptance criteria for an AI/ML powered medical device. The acceptance criteria and testing detailed in the document are for traditional medical device performance, such as dimensions, material properties, leakage, tensile strength, and biocompatibility. There is no mention of AI models, test sets for AI performance, expert ground truth establishment, or MRMC studies.
Therefore, I cannot fulfill your request for information regarding AI/ML acceptance criteria and study details based on the provided text.
If you are looking for an example of how such a request would be answered for an AI/ML device, please provide a document that discusses an AI/ML powered medical device and its validation.
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April 17, 2024
Hangzhou Primecare Medical Co., Ltd. Li Xuedong Regulatory Director Room 408-409, Zancheng Center West, Shangcheng District Hang zhou, Zhe jiang 310008 China
Re: K240039
Trade/Device Name: Enteral Feeding Sets Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIF, KNT, Dated: March 18, 2024 Received: March 18, 2024
Dear Li Xuedong:
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 (the 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 available 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.
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
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
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Indications for Use
Submission Number (if known)
Device Name
Enteral Feeding Sets
Indications for Use (Describe)
Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
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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Image /page/4/Picture/1 description: The image shows the logo for PrimeCare Medical. The word "PrimeCare" is written in a cursive, blue font. Below "PrimeCare" is the word "MEDICAL" in a smaller, sans-serif font, also in blue. A curved line underlines the word "MEDICAL".
510(k) Summary - K240039
Device Trade Name: Enteral Feeding Sets
Common Name: Enteral Feeding Sets
Classification Name: Gastrointestinal tube and accessories
Product Code: KNT, PIF
Regulation: 876.5980
Regulatory Class: Class II
Submitter/Manufacturer:
Hangzhou Primecare Medical Co., Ltd. Room 408-409, Zancheng Center West, Shangcheng District, Hangzhou Zhejiang 310008 China Tel: 86-571-81958620 Regulatory Contact: Li Xuedong, Regulatory Director
Predicate Device
Device Trade Name: CONOD Enteral Feeding Sets 510(k) Number: K181276 Classification: Class II, 876.5980, Gastrointestinal tube and accessories Product Code: KNT, PIF
Device Description
The Enteral Feeding Sets have four models, Enteral Feeding Pump bag Set, Enteral Feeding Pump EnPlus spike Set, Enteral Feeding Gravity bag Set, Enteral Feeding Gravity EnPlus spike Set. The Enteral Feeding Pump bag Set and Enteral Feeding Gravity bag Set both have a structure of a formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. Enteral Feeding Pump EnPlus spike Set and Enteral Feeding Gravity EnPlus spike Set feature a piercing spike (with or without screw cap) used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
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Image /page/5/Picture/1 description: The image shows the logo for PrimeCare Medical. The word "PrimeCare" is written in a cursive, blue font. Below that, the word "MEDICAL" is written in a smaller, sans-serif font, also in blue. A curved line underlines the word "PrimeCare".
Intended Use / Indications for Use
Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
Technological Comparison
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The subject device has the same intended use as the predicate device, dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution, and uses the same technology.
-
The subject device has the same technological characteristics and provide the same principle of operation as the predicate device.
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The differences:
- The predicate device has only 1200ml volume bags, the subject device adds different volumes (1200ml,1000ml,500ml,100ml), Material and intended used are the same.
- The subject device adds one universal screw cap(with or without) to the spike set to extend the connectivity for different pre-filled formula containers. Material of the screw cap is exactly same as ENPlus spike.
- The subject device adds a new model that replaces the built-in enteral bag with ENPlus spike and screw cap so that it can connects to the pre-filled nutrition containers instead of having to prepare formula by the user. the ENPlus spike and screw cap introduced in this set is the same as those used in Enteral feeding pump EnPlus Spike sets.
- The subject device removes the EnFit transitional connector.
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Image /page/6/Picture/1 description: The image shows the logo for PrimeCare Medical. The word "PrimeCare" is written in a stylized, cursive font in blue. Below "PrimeCare" is the word "MEDICAL" in smaller, block letters, also in blue. A curved line underlines the word "MEDICAL".
Shown below is a side by side comparison of the subject device with the predicate device. A
| DeviceCharacteristic | Subject device | Predicate device(K181276) | Results |
|---|---|---|---|
| Device name | Enteral Feeding Sets | CONOD Enteral Feeding Sets | same |
| Indications forUse | Enteral Feeding Sets are intended to dispense liquid nutrition(feeding solutions) at a user controlled rate. These enteralfeeding sets interface with a patient's feeding tube and may usegravity or an enteral feeding pump to dispense feeding solution.The enteral feeding sets include a bag to contain the feedingsolution and/or a EnPlus spike to connect to a pre-filledcontainer. The device is used for infants, children, adolescentsand adults. | CONOD Enteral Feeding Sets are intended to dispenseliquid nutrition (feeding solutions) at a user controlled rate.These enteral feeding sets interface with a patient'sfeeding tube and may use gravity or an enteral feedingpump to dispense feeding solution. The enteral feedingsets include a bag to contain the feeding solution and/or apiercing spike to connect to a pre-filled container. Thedevice is used for infants, children, adolescents and adults. | same |
| Product code | PIF, KNT | PIF, KNT | same |
| Classificationregulation | 21 CFR 876.5980 | 21 CFR 876.5980 | same |
| Deviceconfigurations | ● Enteral Feeding Pump bag Set (1200ml、1000ml、500ml、100ml)■ 1200ml/1000ml/500ml/100ml Enteral Bag withclosure cap■ PVC tubing■ Roller clamp■ Drip chamber■ Silicone tube■ Silicone tube connector■ Warning label■ EnFit connector■ Protection cap for the EnFit connector | ● CONOD Feeding Pump Set (1200ml)■ 1200ml Enteral Bag with closure cap■ PVC tubing■ Roller clamp■ Drip chamber■ Silicone tube■ Silicone tube connector■ Warning label■ EnFit connector■ EnFit transitional connector■ Protection cap for the transition connector | Similar1.Adding different bag volume.Material and intended used are thesame.2. Remove the EnFittransitional connector. |
| ● Enteral Feeding Pump EnPlus spike Set■ Universal screw cap (with or without)■ Protection cap for the spike■ ENPlus spike | ● CONOD Safety spike plus Pump Set■ Protection cap for the spike■ ENPlus spike■ PVC tubing■ Roller clamp | Similar1.Adding one universal screw capto the spike set to extend the | |
| PVC tubing Roller clamp Drip chamber Silicone tube Silicone tube connector Warning label EnFit connector Protection cap for the EnFit connector | Drip chamber Silicone tube Silicone tube connector Warning label EnFit connector EnFit transitional connector Protection cap for the transition connector | connectivity for different pre-filled formula containers.2.Material of the screw cap isexactly same as ENPlus spike.3.Remove the EnFit transitionalconnector. | |
| Enteral Feeding Gravity bag Set (1200ml、1000ml、500ml、100ml) 1200ml/1000ml/500ml/100ml Enteral Bag withclosure cap PVC tubing Roller clamp Drip chamber Warning label EnFit connector Protection cap for the EnFit connector | CONOD Gravity Feeding Set (1200ml) 1200ml Enteral Bag with closure cap PVC tubing Roller clamp Drip chamber Warning label EnFit connector EnFit transitional connector Protection cap for the transition connector | Similar1.Adding different bag volumeMaterial and intended used are thesame.2.Remove the EnFit transitionalconnector. | |
| Enteral Feeding Gravity EnPlus spike Set Universal screw cap (with or without) Protection cap for the spike ENPlus spike PVC tubing Roller clamp Drip chamber Warning label EnFit connector Protection cap for the EnFit connector | CONOD Gravity Feeding Set (1200ml) 1200ml Enteral Bag with closure cap PVC tubing Roller clamp Drip chamber Warning label EnFit connector EnFit transitional connector Protection cap for the transition connector | Different1.Replacing the built-in enteralbag with ENPlus spike and screwcap so that it can connects to thepre-filled nutrition containersinstead of having to prepareformula by the user. the ENPlusspike and screw cap introduced inthis set is the same as those used inEnteral feeding pump EnPlusSpike sets | |
| 2.Remove the EnFit transitionalconnector. | |||
| Design feature | Non DEHP material sets featuring ISO 80369-3:2016 connector | Non DEHP material sets featuring ISO 80369-3:2016 connector | same |
| Materials | PVC、ABS、Silicone、LDPE、paper | PVC、ABS、Silicone、LDPE、paper | same |
| Prescription use or not | Prescription use | Prescription use | same |
| Disposable or not | Disposable for single use | Disposable for single use | same |
| Intended use time | No longer than 24 hours | No longer than 24 hours | same |
| Sterile or not | Non-sterile | Non-sterile | same |
| Shelf-life | 5 years | 5 years | same |
| Available tube lengths | Enteral Feeding Pump bag Set: 60cm+157cmEnteral Feeding Pump EnPlus spike Set: 60cm+157cmEnteral Feeding Gravity bag Set: 170cmEnteral Feeding Gravity EnPlus spike Set: 170cm | Pump set: 60cm+157cmSpike set: 60cm+157cmGravity set: 170cm | Similar |
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Image /page/7/Picture/2 description: The image contains the logo for PrimeCare Medical. The logo is in blue and consists of the word "PrimeCare" in a script font, with the word "MEDICAL" in smaller, block letters underneath. A curved line underlines the word "MEDICAL".
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Image /page/8/Picture/1 description: The image shows the logo for PrimeCare Medical. The word "PrimeCare" is written in a stylized blue font. Below "PrimeCare" is the word "MEDICAL" in a smaller, sans-serif font, also in blue. A curved blue line underlines the word "MEDICAL".
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Image /page/9/Picture/1 description: The image shows the logo for PrimeCare Medical. The word "PrimeCare" is written in a cursive, blue font. Below "PrimeCare" is the word "MEDICAL" in a smaller, sans-serif font, also in blue. A curved line underlines the word "MEDICAL".
Summary of Non-Clinical Testing
The non-clinical bench performance testing of the Enteral Feeding Sets is tested according to ISO 80369-3:2016(5-123), ISO20695:2020(9-138), ISO18250-3:2018(5-139), IEC62366-1:2020(5-129), ISO 10993 series of biological standards, Packaging test related standards and the guidance: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications.
Table 1: Metrology (include EnFit connector, ENPlus spike & screw cap)
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Dimensions (EnFit connector) | ISO 80369-3:2016 | Meet the requirements |
| 2 | Dimensions (ENPlus spike) | ISO 18250-3:2018 | Meet the requirements |
| 3 | Dimensions (screw cap) | ISO 18250-3:2018 | Meet the requirements |
Table 2: Appearance inspection
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Deformed parts, Cracking andburr, Incomplete seal orbreakage of bag,Kinked tube | Study in-house | None |
| 2 | Bag Printing | Study in-house | Present |
Table 3: EnFit connector performance testing
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Fluid leakage(Leakage by pressuredecay) | ISO 80369-3:2016 | shall not leak by more than0.005 Pa.m³/s |
| 2 | Stress cracking | ISO 80369-3:2016 | No signs of leakage |
| 3 | Resistance toseparation from axialload | ISO 80369-3:2016 | shall not separate from thereference connector |
| 4 | Resistance toseparation fromunscrewing | ISO 80369-3:2016 | shall not separate from thereference connector |
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Image /page/10/Picture/1 description: The image contains the logo for PrimeCare Medical. The word "PrimeCare" is written in a cursive, blue font. Below "PrimeCare" is the word "MEDICAL" in a smaller, sans-serif font, also in blue. A curved line underlines the word "MEDICAL".
| 5 | Resistance tooverriding | ISO 80369-3:2016 | shall not override the threadsor lugs of the referenceconnector |
|---|---|---|---|
| 6 | Disconnection byunscrewing | ISO 80369-3:2016 | shall separate from thereference connector with anapplied unscrewingtorque of no greater than 0.35N·m |
Table 4: ENPlus spike & screw cap performance testing
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Positive pressure liquidleakage | ISO 18250-3:2018 | shall show no signs ofleakage |
| 2 | Subatmospheric-pressureair leakage | ISO 18250-3:2018 | shall not leak by more than0.005 Pa.m3/s |
| 3 | Stress cracking | ISO 18250-3:2018 | No signs of leakage |
| 4 | Resistance to separationfrom axial load | ISO 18250-3:2018 | shall not separate from thereference connector. |
| 5 | Resistance to separationfrom unscrewing | ISO 18250-3:2018 | shall not separate from thereference connector |
| 6 | Resistance to overriding | ISO 18250-3:2018 | shall not override thethreads or lugs of thereference connector |
Table 5: Enteral Feeding Sets performance testing
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Tensile strength | ISO 20695-2020 | shall withstand a tensileforce of 15 N beforebreaking, becomingdetached, or cracking |
| 2 | Leakage | ISO 20695-2020 | shall not show signs ofleakage sufficient toform a falling drop ofwater |
| 3 | Flow rate | ISO 20695-2020Study in-house | Meet the requirements |
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Image /page/11/Picture/1 description: The image shows the logo for PrimeCare Medical. The word "PrimeCare" is written in a cursive, blue font. Below "PrimeCare" is the word "MEDICAL" in a smaller, sans-serif, blue font. There is a curved line underneath the word "MEDICAL".
Hangzhou Primecare Medical Co., Ltd. Table 6: Packaging performance testing
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Visual inspection | ASTMF1886/F1886M-16 | No defect of the integrityof seals must be found |
| 2 | Seal strength test | ASTM F88/F88M-21Study in-house | Should not be less than12 N/15mm |
Table 7: biological test
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 | Non-Cytotoxic |
| 2 | Sensitization | ISO 10993-10:2021 | Non-Sensitizer |
| 3 | IntracutaneousIrritation | ISO 10993-23:2021 | Non-Irritant |
Table 8: Usability Study
| No. | Items | Standards | Acceptance criteria |
|---|---|---|---|
| 1 | Usability Study | IEC 62366-1:2020 | Meet the requirements |
Summary of Clinical Testing
Clinical testing was not required for device evaluation.
Conclusion
The conclusions drawn from the nonclinical testing for the subject device, Enteral Feeding Sets, demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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.