(144 days)
The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.
The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single use. This is accomplished by an electrical diaphragm pump generating a suck and release vacuum pattern. The suction strength is adjustable. The pumping device is sealed via a connection ring to a breast shield equipped with a valve separating the breast shield from the bottle.
Here's an analysis of the provided text regarding the NUK Breast Pump (K101157) and its acceptance criteria, focusing on the requested information.
It's important to note that the provided 510(k) summary is for a medical device that does not involve an AI/ML algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this type of document. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards.
Acceptance Criteria and Reported Device Performance for NUK Easy-Flow Single Electric Breast Pump (K101157)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from device specifications or recognized standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Express milk from the breast by a single user | The device is intended for use to express milk from the breast by a single user. (This implies performance meets the intended function) |
| FDA Classification | 21 CFR 884.5160 (Powered breast pump) and Classification Code HGX/HGZ | Complies with 21 CFR 884.5160 and Classification Code HGZ |
| Indication for Use | Powered breast pump to express milk from the breast | The NUK breast pump is intended for use to express milk from the breast of a single user. |
| Intended Users | Lactating women | For use by lactating women |
| Availability | Over-the-counter | Available over the counter |
| Portability | Portable device | Portable |
| Vacuum Range | Functionally appropriate for breast milk expression (Predicate's not specified) | Maximum 250mmHg |
| Suction Mode | Adjustable | Adjustable |
| Type of Pump | Electric/Battery operated | Electric/Battery |
| Closed System | Yes | Yes |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant (as per performance testing) |
| Electrical Safety | IEC 60601-1 / EN 60601-1 compliant (or relevant standard) | ISO 60601-1 compliant (as per performance testing) |
| General Performance | Conformance with internal company specifications (comparable to predicate) | The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. |
Study Proving Device Meets Acceptance Criteria
The document states: "The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicate. Additional performance testing was completed for biocompatibility and electrical safety to recognized standards."
This indicates that internal verification and validation studies were conducted according to the company's design control processes and relevant recognized standards. The 510(k) process primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than entirely novel clinical efficacy studies.
Specifically:
- Substantial Equivalence Comparison: A detailed table compares the subject device (NUK Easy-Flow Electric Breast Pump) to the predicate device (miPump Electric Breast Pump K082802) across various specifications (FDA classification, intended use, users, portability, vacuum range, suction mode, pump type, closed system, biocompatibility, electrical safety). The conclusion is that they have "substantially equivalent intended use and technological specifications."
- Biocompatibility Testing: Confirmed compliance with ISO 10993.
- Electrical Safety Testing: Confirmed compliance with ISO 60601-1.
2. Sample Size Used for the Test Set and Data Provenance
Given this is a 510(k) for a hardware medical device (breast pump) and not an AI/ML diagnostic, there isn't a "test set" in the sense of a dataset for an algorithm. The "testing" refers to physical product testing and design verification.
- Sample Size for Test Set: Not specified in terms of a "data set" for an algorithm. It would refer to the number of physical units tested for engineering specifications, durability, etc., but this detail is not provided in a 510(k) summary (which focuses on the conclusion of testing).
- Data Provenance: Not applicable in the context of an AI/ML algorithm's dataset. The "data" here would be test results from manufacturing and engineering verification, originating from the manufacturer's (MAPA GmbH, Germany) internal testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not an AI/ML device requiring expert consensus for a "ground truth" dataset. The "truth" for device performance is established through engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication for a data set is mentioned or relevant for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device does not incorporate AI, therefore, no studies comparing human readers with and without AI assistance were conducted.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device does not incorporate an AI algorithm.
7. Type of Ground Truth Used
Not applicable in the context of an AI/ML algorithm. The "ground truth" for this device's performance is established by engineering specifications, recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 60601-1 for electrical safety), and the functional requirements for a breast pump.
8. Sample Size for the Training Set
Not applicable. This device does not use a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not use a training set for an AI/ML algorithm.
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K101157 - NUK Breast Pump - Mapa GmbH
SEP 1 7 2010
510(k) Summary Prepared August 12, 2010
Submitted by: MAPA GmbH Industriestrasse 21-25 Zeven, GERMANY 27404 Contact Person: Reinhold Jaeger-Waldau Telephone: 049-4281-730-420 e-mail: reinhold.jaeger-waldau@mapa.de Product Name: NUK Easy-Flow Single Electric Breast Pump Common Name: Electric Breast Pump Classification: Breast Pump, HGX, 21CFR 884.5160 miPump Single Electric Breast Pump Predicate Device:
Description of Device:
The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single use. This is accomplished by an electrical diaphragm pump generating a suck and release vacuum pattern. The suction strength is adjustable. The pumping device is sealed via a connection ring to a breast shield equipped with a valve separating the breast shield from the bottle.
Intended Use:
The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.
Comparison with Predicate Devices:
The submission device and the predicate device have substantially equivalent intended use and technological specifications.
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K101157 page 2 of 2
K101157 - NUK Breast Pump - Mapa GmbH
| Predicate Device | Subject Device | |
|---|---|---|
| miPump Electric Breast Pumpby Learning Curve K082802 | NUK Easy-Flow Electric Breast PumpMAPA GmbH | |
| FDA classification | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Classification Code | HGZ | HGZ |
| Indication for Use | Powered breast pump to express milk from the breast | The NUK breast pump is intended for use to express milk from the breast of a single user |
| Intended Users | Lactating women | Lactating women |
| Available over the counter | Yes | Yes |
| Portable | Yes | Yes |
| Vacuum range | Not specified in device labeling | Maximum 250mmHg |
| Suction mode | adjustable | Adjustable |
| Type of pump | Electric/Battery | Electric/Battery |
| Closed System | Yes | Yes |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant |
| Electrical Safety | Not specified in device labeling | ISO 60601-1 compliant |
Performance:
The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicate. Additional performance testing was completed for biocompatibility and electrical safety to recognized standards.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The background is white. The text is centered in the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.
Sheila W. Pickering, Ph.D. Consultant Mapa GmbH 2081 Longden Circle LOS ALTOS CA 94024
Re: K101157
Trade Name: NUK Easy-Flow Single Electric Breast Pump Regulation Number: 21 CFR $884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: August 16, 2010 Received: August 24, 2010
SEP 1 7 2010
Dear Dr. Pickering:
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'. 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
Image /page/2/Picture/10 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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K101157 - NUK Breast Pump - Mapa GmbH
SEP 1 7 2010
510(k) Number (if known): K101157
Device Name: NUK Easy-Flow Single Electric Breast Pump
Indications For Use:
"The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user."
Prescription Use OR Over-The-Counter Use (Per 21CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence Of CDRH, Office Of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
027
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).