(272 days)
ENFit Nutrifit™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow. The syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician), to clinicians to administer enteral fluids. ENFit Nutrifit™ enteral syringes are single use devices. ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.
An enteral syringe consists of a syringe barrel with integral tip (ENFit), plunger, gasket, barrel lubricant and can be supplied with or without a syringe tip cap. Only the 5mL single use syringe can be connected with compatible enteral syringe-driver pumps; the other syringes are for manual use.
The provided document is a 510(k) Premarket Notification for ENFit enteral syringes, which are medical devices used for delivering enteral fluids. It outlines the regulatory process for clearance, not a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing and conformance to established standards, rather than clinical studies with human participants.
Therefore, I cannot provide the information requested in the prompt's structured format (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types, training set details) because this document does not describe such a study for an AI/ML powered device.
The document details the following about the device's testing and intended performance:
- Device Type: ENFit enteral syringes (NUTRIFIT™)
- Intended Use: Delivering enteral fluids to the gastrointestinal system of patients unable to eat and swallow. Intended for use in clinical or home care settings by laypersons (under supervision) and clinicians, for pediatric and adult use.
- Regulatory Class: Class II (Product Code: PNR, Regulation Number: 21 CFR 876.5980 - Gastrointestinal tube and accessories).
- Predicate Device: ENFit enteral pump syringes PENTA™/ENFit enteral pump syringes NUTRIFIT™ (K161141).
- Testing and Evaluation:
- Performance test: According to ISO 7886-1/-2 & ISO 80369-3/-20, including testing after simulated clinical use and cleaning.
- Biocompatibility tests: According to ISO 10993 series requirements.
- Sterility validation and tests: According to ISO 11135.
- Packaging validation and tests: According to ISO 11607-1/-2.
- Labeling requirements: According to ISO 15223-1 and FDA Guidance "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications."
- Conclusion: The tests demonstrated that the ENFit enteral syringes NUTRIFIT™ are safe and effective, meet their intended use, and are similar to the predicate device in terms of intended use, indications for use, and medical technique.
The document emphasizes compliance with international standards (ISO) and FDA guidance for medical devices, specifically for physical characteristics, sterility, biocompatibility, and packaging, rather than performance metrics related to diagnostic accuracy, image interpretation, or other tasks that would involve AI/ML algorithms and require the types of studies outlined in your request.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
February 28, 2022
Pentaferte Italia S.R.L. % Stephanie Rose Regulatory Affairs Manager Vygon USA 2750 Morris Rd Suite A200 Lansdale, PA 19446
Re: K211661
Trade/Device Name: ENFit enteral syringes (NUTRIFIT) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: January 26, 2022 Received: January 28, 2022
Dear Lauren Doyle:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (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-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,
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
510(k) Number (if known) K211661
Device Name ENFit enteral syringes (NUTRIFIT)
Indications for Use (Describe) Nutrifit™ Single Use /Enteral Syringes with ENFit Connector (including low dose tip (LDT) versions):
ENFit Nutrifif™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow.
The syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician), to clinicians to administer enteral fluids.
ENFit Nutrifit™ enteral syringes are single use devices.
ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for PentaFerte. The logo has a stylized letter "P" on the left side, with the top part of the "P" in red and the bottom part in black. To the right of the "P" is the word "PentaFerte", with "Penta" in black and "Ferte" in red. Below the word "PentaFerte" is the text "ITALIA MEDICAL DEVICES SOLUTIONS", with "ITALIA" in red and the rest of the text in black.
Additional Information Response to Traditional 510(k) Notification K211661 ENFit enteral syringes NUTRIFIT™ Author: Stephanie Rose, Date: January 26, 2022
| Submitter's Name | Pentaferte Italia S.r.l. |
|---|---|
| Address | Viale Piane Nocella, 23,I-64012 Campli (TE) - Italy |
| Establishment RegistrationNumber | 3004756837 |
| Summary Preparation Date | January 26, 2022 |
| Contact Person | Stephanie Rose |
| Telephone Number | 1(603)403-0809 |
| Fax Number | 1(215)672-6740 |
| Name of Device | ENFit enteral syringes NUTRIFIT ™ |
| Common name of Device | ENFit enteral syringes |
| Classification Name and Class | Gastrointestinal tube and accessoriesDevice Class: IIProduct Code: PNRRegulation Number 21 CFR 876.5980 |
| Performance Standards | ISO 80369-3:2016 - Small-bore connectors for liquids and gases inhealthcare applications -- Part 3: Connectors for enteral applicationsISO 7886-1:2018 - Sterile hypodermic syringes for single useISO 7886-2:2020 "Sterile hypodermic syringes for single use - Syringesfor use with power driven syringes"ISO 80369-20:2015 - Small-bore connectors for liquids and gases inhealthcare applications - Part 20: Common test reportsISO 11135: 2014 - Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of asterilization process for medical devices.ISO 11737-1:2018 - Sterilization of health care products - Microbiologicalmethods - Part 1: Determination of a population of microorganisms onproductsISO 14971:2020 - Medical devices - Applications of risk management tomedical devicesISO 15223-1:2016 - Medical devices - Symbols to be used with medicaldevices labels, labeling, and information to be supplied - Part 1: GeneralrequirementsISO 11607-1:2019 - Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packagingsystemsISO 11607-2:2019 - Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assemblyprocessesASTM F1980: 2016 - Standard guide for accelerated aging of sterilemedical device packagesISO 10993-1:2018 - Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management processISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: |
510(k) SUMMARY, AS REQUIRED BY 21 CFR 807.92 4
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Image /page/4/Picture/1 description: The image is a logo for PentaFerte. The logo has a stylized letter "P" on the left, with the top part of the "P" in red and the bottom part in black. To the right of the "P" is the word "PentaFerte", with "Penta" in black and "Ferte" in red. Below the word "PentaFerte" is the text "ITALIA MEDICAL DEVICES SOLUTIONS", with "ITALIA" in red and the rest of the text in black.
Additional Information Response to Traditional 510(k) Notification K211661 ENFit enteral syringes NUTRIFIT™ Author: Stephanie Rose, Date: January 26, 2022
| Tests for in vitro cytotoxicityISO 10993-10:2013 - Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization | |||
|---|---|---|---|
| ENFit enteral syringes are designed to reduce the accidental risk ofconnection to a parenteral system, as required by ISO 80369-3:2016,allowing only enteral use. The syringes are available in single useconfigurations. | |||
| Description of Device | An enteral syringe consists of a syringe barrel with integral tip (ENFit),plunger, gasket, barrel lubricant and can be supplied with or without asyringe tip cap. | ||
| Only the 5mL single use syringe can be connected with compatibleenteral syringe-driver pumps; the other syringes are for manual use. | |||
| Nutrifit™ Single Use /Enteral Syringes with ENFit Connector (includinglow dose tip (LDT) versions): | |||
| Indications for Use | ENFit Nutrifit™ enteral syringes deliver enteral fluids to thegastrointestinal system of a patient who is physically unable to eat andswallow.The syringes are intended to be used in clinical or home care settings byusers ranging from laypersons (under the supervision of a clinician), toclinicians to administer enteral fluids.ENFit Nutrifit™ enteral syringes are single use devices.ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use. | ||
| The following predicate devices have been identified: | |||
| Predicate Device: | |||
| Device ClassificationName: | Enteral Syringes With Enteral SpecificConnectors | ||
| 510K Number: | K161141 | ||
| Identification of PredicateDevice | Trade/Device Name: | ENFit enteral pump syringes PENTA ™ENFit enteral pump syringes NUTRIFIT™ | |
| Regulation Number: | 21 CFR 876.5980 | ||
| Regulation Name: | Gastrointestinal Tube and Accessories | ||
| Regulatory Class: | II | ||
| Product Code: | PNR | ||
| Applicant: | PENTAFERTE ITALIA S.R.L. | ||
| VIALE PIANE NOCELLA, 23Campli, IT I-64012 | |||
| In vitro bench testing was performed to support a determination ofsubstantial equivalence (refer to performance testing below) betweenENFit enteral syringes NUTRIFIT™, and predicate device. | |||
| Performance Summary | The results of these tests provide reasonable assurance that theproposed device has been designed and tested to assure conformance to |
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Image /page/5/Picture/1 description: The image is a logo for PentaFerte. The logo has a stylized letter "P" on the left, with the top part in red and the bottom part in black. To the right of the "P" is the word "Penta" in black and "Ferte" in red. Below the word "PentaFerte" is the text "ITALIA MEDICAL DEVICES SOLUTIONS" with "ITALIA" in red and the rest of the text in black.
Additional Information Response to Traditional 510(k) Notification K211661 ENFit enteral syringes NUTRIFIT™ Author: Stephanie Rose, Date: January 26, 2022
| the requirements for its intended use and performs comparably to theexisting predicate device. | |
|---|---|
| In vitro bench tests were carried out, according to the requirements ofFDAs document Guidance for Industry and FDA Staff: Format forTraditional and Abbreviated 510(k)s and applicable standards. Thefollowing areas have been tested and/or evaluated:Performance test according to ISO 7886-1/-2 & ISO 80369-3/-20including testing after simulated clinical use and cleaningBiocompatibility tests according to ISO 10993 series requirementsSterility validation and tests according to ISO 11135Packaging validation and tests according to ISO 11607-1/-2Labelling requirements according to ISO 15223-1 and FDA Guidance"Safety Considerations to Mitigate the Risks of Misconnections withSmall-bore Connectors Intended for Enteral Applications" | |
| Results from these evaluations demonstrated that the ENFit enteralsyringes NUTRIFIT ™ are safe and effective to meet their intended use.ENFit enteral syringes NUTRIFIT™ are similar to the predicate device in | |
| terms of intended use, indications for use, and medical technique. | |
| Substantial Equivalence | Based on the safety and performance testing, technologicalcharacteristics, and the indications for use for the device, the proposedENFit enteral syringes NUTRIFIT™, have been demonstrated to beappropriate for its intended use and is considered substantiallyequivalent to the ENFit Enteral Pump Syringes PENTA ENFit/ENFit Enteral |
Table 3 – Summary Table
§ 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.