(26 days)
The COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).
The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike with 1000 mL water bag is compatible with all SpikeRight compatible enteral feeding systems. The twist and lock feature ensures safe and effective connection and prevents inadvertent connections to IV sets. The 1000 mL formula vinyl bag with 1000 mL water bag has 50 mL graduations to make it easier for reading and better accuracy when filling. The different-colored print on the bags make it easy to identify water and formula and the nutrition orders can be written directly on the formula bag for convenience. Single Use Only.
The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike is compatible with all SpikeRight compatible enteral feeding systems. The COMPAT pump set with the in-line "Y" adapter is DEHP and latex free. Easy to use "Y" adapter - simply disconnect "Y" adapter cap and insert syringe for flushing. The in-line "Y" saves time - no need to disconnect set from the feeding tube when flushing medications, water or bolus feeding. Ready to use. Single use only.
The provided text is for a 510(k) premarket notification for a modified medical device. This type of document is about regulatory clearance for a device based on its substantial equivalence to a predicate device, not about a study proving the device meets clinical acceptance criteria in terms of diagnostic performance or efficacy for AI/imaging devices.
Therefore, the information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set size and ground truth establishment) is not applicable to this document.
Manufacturers use bench testing and engineering verification to demonstrate that a modified device functions as intended and meets its design specifications, and that these specifications are equivalent to the predicate device. The statement "All test results verify that the device meets or exceeds all predetermined specifications" confirms this. However, the specific details of these technical specifications and their corresponding test results are generally proprietary and not included in the public 510(k) summary.
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K080346
lot 3
SMDA Summary – Special 510(k) Modified Device
| Submitted by: | Nestlé HealthCare Nutrition, Inc.12500 Whitewater DriveMinnetonka, MN 55343 | MAR - 5 2008 |
|---|---|---|
| Contact Person: | Thomas A. DoldAssociate Director, Regulatory Affairs – Medical DevicesNestlé HealthCare Nutrition, Inc.Phone: 952.848.6480Fax: 952.848.6319 | |
| Summary Date: | February 5, 2008 | |
| Proprietary Name: | COMPAT® DualFlo™ Enteral Delivery Pump Set withSpikeRight™ Piercing Spike and 1000 mL Water BagCOMPAT® Y Set. Pump Set with In Line "Y: Adaptor andSpikeRight™ Piercing Spike | |
| Common Name: | Tubes, Gastrointestinal and Accessories | |
| CFR Reference: | 21CFR§ 876.5980 | |
| Class: | II | |
| Product Code: | KNT | |
| Equivalent marketed device: | K940555 - Sandoz Nutrition COMPAT Enteral Feeding Pump withHydrationK940556 - Sandoz Nutrition COMPAT Enteral Feeding Pump |
Nestlé Healthcare Nutrition, Inc.
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Device Description:
COMPAT® DualFlo™ Enteral Delivery Pump Set with SpikeRight™ Piercing Spike and 1000 mL Water Bag
The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike with 1000 mL water bag is compatible with all SpikeRight compatible enteral feeding systems. The twist and lock feature ensures safe and effective connection and prevents inadvertent connections to IV sets. The 1000 mL formula vinyl bag with 1000 mL water bag has 50 mL graduations to make it easier for reading and better accuracy when filling. The different-colored print on the bags make it easy to identify water and formula and the nutrition orders can be written directly on the formula bag for convenience. Single Use Only.
COMPAT® Y Set. Pump Set with In Line "Y: Adaptor and SpikeRight™ Piercing Spike
The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike is compatible with all SpikeRight compatible enteral feeding systems. The COMPAT pump set with the in-line "Y" adapter is DEHP and latex free. Easy to use "Y" adapter - simply disconnect "Y" adapter cap and insert syringe for flushing. The in-line "Y" saves time - no need to disconnect set from the feeding tube when flushing medications, water or bolus feeding. Ready to use. Single use only.
Intended Use:
The COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).
Technological Characteristics:
The modified device has the same basic technological characteristics as the predicate device. The modified device is equivalent in terms of design, functionality, principles of operation, performance specifications and intended use. When compared to the unmodified device, the modified device raises no new technological issues.
Substantial Equivalence Rationale:
Based on design, technological characteristics, intended use, and extensive testing, Nestlé HealthCare Nutrition, Inc. believes that the modified device is substantially equivalent to the unmodified predicate device currently marketed under 510(k) K940555 and K940556
The modified device raises no new issues of safety or effectiveness.
Nestlé Healthcare Nutrition, Inc.
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Test Conclusions:
Nestlé HealthCare Nutrition, Inc. has conducted extensive testing of the modified device to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR - 5 2008
Mr. Thomas A. Dold Associate Director of Regulatory Affairs Nestlé Healthcare Nutrition, Inc. 12500 Whitewater Dr. MINNETONKA MN 55343
Re: K080340
Trade/Device Name: COMPAT® Enteral Delivery Pump Sets with SpikeRight™ Piercing Spike Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Produce Code: KNT Dated: February 5, 2008 Received: February 8, 2008
Dear Mr. Dold:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal, and the word "Centennial" is below the letters. There are other words around the edge of the seal, but they are not legible.
Protecting and Promoting Public Health.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE 9.0
INDICATIONS FOR USE
510(k) Number (if known):
680340
Device Name: COMPAT® Enteral Delivery Pump Sets with SpikeRight™ Piercing Spike
Indications for Use:
The COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heila Lewis
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Nestié Healthcare Nutrition, Inc.
§ 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.