(143 days)
No
The summary describes enteral delivery pump sets and their performance testing, with no mention of AI or ML.
No
The device is an enteral delivery pump set, which is intended to deliver liquid nutrition or hydration. It does not treat or diagnose a disease or condition itself.
No
Explanation: The device is described as an enteral delivery pump set intended to deliver liquid nutrition or hydration, not to diagnose a condition.
No
The device description explicitly states it is comprised of "Five configurations of enteral delivery sets," which are physical components (bags, spikes, etc.) for delivering liquid nutrition. The performance studies also focus on bench testing of these physical components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver liquid nutition formulas or hydration to an enteral access device (a feeding tube)." This describes a device used for administering substances directly into the body, not for testing samples taken from the body.
- Device Description: The description details "enteral delivery sets" for administering liquid nutrition or hydration. This aligns with the intended use and does not suggest any diagnostic testing function.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Performance Studies: The performance studies listed are focused on the physical and functional aspects of the delivery sets (flow rate, bond strength, leakage, biocompatibility, etc.), not on the accuracy or performance of a diagnostic test.
Therefore, based on the provided information, the Compat® Enteral Delivery Pump Sets are medical devices used for administering nutrition/hydration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Compat® Enteral Delivery Pump Sets are intended to deliver liquid nutition formulas or hydration to an enteral access device (a feeding tube).
Product codes
PIF
Device Description
Five configurations of enteral delivery sets: Standard Bag, Standard SpikeRight® PLUS, DualFlo Bag/SpikeRight PLUS, DualFlo Bag/Bag and Gravity Set for administering liquid nutrition or hydration to an enteral access device (feeding tube).
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
Not Found
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
Performance testing was conducted on the Compat Enteral Delivery Administration Sets, including:
- Risk Assessment of the Administration Sets including Failure Modes and Effects Criticality Analysis (FMECA)
- ENFit component verification testing
- ENFit bond strength testing
- PGLOCK Administration Validation Testing
- ASTM D638-10: Standard Test Method for Tensile Properties of Plastics
- Performance testing with and without reference connectors:
- Falling drop positive pressure liquid leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
- Falling drop positive pressure liquid leakage after 20 cycles
- Enteral Connector Misconnection Assessment Study
- Failure Modes and Effects Analysis (FMEA)
- Risk Analysis
- Human Factors Testing
- Biocompatibility Testing (ISO 10993)
- Part 5: Tests for Invitro Cytotoxicity
- Part 10: Tests for Irritation and Delayed-Type Hypersensitivity — Intracutaneous Study (rabbits)
- Part 10: Tests for Irritation and Delayed-Type Hypersensitivity – Sensitization Study (guinea pig)
- Flow Rate Testing to assure ENFit flow rate equals or exceeds step connector flow rate
Performance Testing (Animal): None provided
Performance Testing (Clinical): None provided
Substantial Equivalence Rationale: The Compat Enteral Delivery Administration Sets are substantially equivalent to the approved Nestlé Healthcare Nutrition administration sets except for the replacement of the distal AAMI ID54 ("Christmas tree" or "step") connector with the ENFit connector tested in accordance with ISO 80369-1.
Key Metrics
Not Found
Predicate Device(s)
COMPAT DualFlo® Enteral Delivery Pump Set with SpikeRight Piercing Spike and 1000 mL Water Bag K080340
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2014
Nestle HealthCare Nutrition, Inc. % M.W. (Andy) Anderson, Ph.D., RAC Senior Principal Advisor, Regulatory Affairs and Quality Systems Regulatory & Clinical Research Institute, Inc. (RCRI) 5353 Wayzata Boulevard. Suite 505 Minneapolis, MN 55416
Re: K140947
Trade/Device Name: Compat® Enteral Delivery Pump Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: August 15, 2014 Received: August 18, 2014
Dear M.W. (Andy) Anderson,
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. 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.
1
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); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4.0 Indication for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
N/A K140947
Device Name
Compat® Enteral Delivery Pump Set
Indications for Use (Describe)
The Compat® Enteral Delivery Pump Sets are intended to deliver liquid nutition formulas or hydration to an enteral access device (a feeding tube).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Summary (21 CFR § 807.92)
| Submitter: | Nestlé HealthCare Nutrition, Inc. |
|---|---|
| Contact: | Thomas A. Dold |
| Date Prepared: | 29 August 2014 |
| Establishment Registration | |
| Number: | 2110851 |
| Trade Name: | Compat® Enteral Delivery Pump Sets |
| Common Name: | Tubes, gastrointestinal and accessories |
| Device Classification: | Gastrointestinal Tubes with Enteral Specific Connectors |
| Class: | II |
| Product Code: | PIF |
| Regulation: | 21 CFR 876.5980 |
| Classification Panel: | Gastroenterology/Urology |
| Predicate Device(s): | COMPAT DualFlo® Enteral Delivery Pump Set with |
| SpikeRight Piercing Spike and 1000 mL Water Bag | |
| K080340 | |
| Device Description: | Five configurations of enteral delivery sets: Standard |
| Bag, Standard SpikeRight® PLUS, DualFlo Bag/SpikeRight | |
| PLUS, DualFlo Bag/Bag and Gravity Set for administering | |
| liquid nutrition or hydration to an enteral access device | |
| (feeding tube). | |
| 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: | Single-use enteral delivery sets consist of PVC tubing, |
| formula/water bag, drip chamber, ABS SpikeRight PLUS | |
| and ENFit connectors with roller or slide clamps. | |
| Performance Testing (Bench): | The following performance testing was conducted on |
| the Compat Enteral Delivery Administration Sets: | |
| ● Risk Assessment of the Administration Sets | |
| including Failure Modes and Effects Criticality | |
| Analysis (FMECA) |
4
- ENFit component verification testing ●
- . ENFit bond strength testing
- PGLOCK Administration Validation Testing
- ASTM D638-10: Standard Test Method for Tensile Properties of Plastics
- Performance testing with and without reference connectors:
- Falling drop positive pressure liquid leakage o
- Stress cracking O
- Resistance to separation from axial load O
- Resistance to separation from unscrewinq O
- Resistance to overriding O
- Disconnection by unscrewing o
- Falling drop positive pressure liquid leakage o after 20 cycles
- . Enteral Connector Misconnection Assessment Study
- Failure Modes and Effects Analysis (FMEA)
- Risk Analysis
- Human Factors Testinq
- Biocompatibility Testing (ISO 10993)
- o Part 5: Tests for Invitro Cytotoxicity
- o Part 10: Tests for Irritation and Delayed-Type Hypersensitivity — Intracutaneous Study (rabbits)
- o Part 10: Tests for Irritation and Delayed-Type Hypersensitivity – Sensitization Study (guinea pig)
- . Flow Rate Testing to assure ENFit flow rate equals or exceeds step connector flow rate
Performance Testing (Animal): None provided
- Performance Testing (Clinical): None provided
Substantial Equivalence The Compat Enteral Delivery Administration Sets are substantially equivalent to the approved Nestlé Rationale: Healthcare Nutrition administration sets except for the replacement of the distal AAMI ID54 ("Christmas tree" or "step") connector with the ENFit connector tested in accordance with ISO 80369-1.