(42 days)
The DEBP is intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
The Double Electric Breast Pump (DEBP) is a powered breast pump. The pumping can be performed on one breast or on both breasts at the same time. The Lansinoh DEBP can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to control cycle speed and vacuum level. The Lansinoh DEBP is capable of providing vacuum levels from 50 to 250 mmHg, with cycling rates up to 1.85 cycles per second.
The provided text describes a 510(k) premarket notification for a Double Electric Breast Pump (DEBP) and includes some performance testing information, but it does not contain a detailed study report with acceptance criteria and results in the format requested.
The document focuses on establishing substantial equivalence to predicate devices and adherence to general safety standards (IEC 60601-1, IEC 60601-1-2).
Here's a breakdown of what can be extracted and what information is missing from the input based on your prompt:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Performance Metric | DEBP Performance (Reported) |
|---|---|
| General Safety and Performance Standards | |
| IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety" | Will be tested to meet |
| IEC 60601-1-2:2007, "Electromagnetic Compatibility" | Will be tested to meet |
| Functional Performance (Comparison to Predicates) | |
| Pumping Suction (Expression Phase) | 50 - 250 mmHg |
| Suction Levels (Stimulation/Let Down Phase) | 50 – 150 mmHg |
| Cycles per Second (Stimulation/Let Down Phase) | 1.85 (fixed) |
| Cycles per Second (Expression Phase) | 0.51 - 1.0 |
| Suction Settings | 8 |
| Back Flow Protection | Yes |
| Let Down Function | Yes |
Missing Information: The document states the DEBP "will be tested to meet" IEC standards, but it does not provide the specific acceptance criteria for these standards within the document or the results proving it has met them. Similarly, the functional performance metrics are presented as device capabilities rather than explicit acceptance criteria from a study with corresponding reported results demonstrating compliance to those criteria specifically.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Missing Information: The document mentions "Performance Testing" including "Suction curves" and a "backflow test." However, it does not provide any details about the sample size (e.g., number of pumps tested), the methodology of these tests, or the data provenance (country of origin, retrospective/prospective). This section only states what will be tested or general capabilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Missing Information: This information is not applicable as the device is a powered breast pump, not an imaging or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Missing Information: This is not applicable for the type of device and testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Missing Information: This is not applicable as the device is a powered breast pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Missing Information: This is not applicable as the device is a powered breast pump, not an algorithm. The "Microcontroller" is a control system, not an AI algorithm for standalone performance evaluation in the context of the prompt.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Missing Information: For the performance tests mentioned (suction curves, backflow), the "ground truth" would likely be engineering specifications and physical measurements, but the specific validation method (e.g. against a calibrated standard) is not detailed.
8. The sample size for the training set:
Missing Information: This is not applicable as the device is a physical product, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Missing Information: This is not applicable for the reason stated above.
In summary: The provided document is a 510(k) summary for regulatory submission, focusing on substantial equivalence and general safety standards. It outlines intended performance capabilities and states that the device "will be tested to meet" certain IEC standards. However, it does not present a detailed study report with specific acceptance criteria, comprehensive performance data from a defined test set, or information relevant to clinical studies, human readers, or AI algorithms, which many of your requested points pertain to.
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OCT 2 2 2009
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for ENKO Ltd.'s premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the DEBP is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).
Applicant: ENKO Ltd. 10006 sokak, No:64 A.O.S.B. Cigli - Izmir 35620 TURKIYE Tel: 0090 232 3767806 Fax: 0090 232 3767792 www.enkoelektronik.com Attn: Sinan Kazazoglu
Contact: Calley Herzog Biologics Consulting Group, Inc. 13417 Quivas St. Westminster, CO 80234 Ph. 720-883-3633 Fax. 720-293-0014
Date of Submission: 07/01/2009
Proprietary Name: DEBP
Common Name: Powered Breast Pump
Regulatory Class: Class II
Product Codes: HGX
Predicate Device(s): Medela swing Breastpump, By Medela Inc. (K053052) & Hollister Inc. Expresse and Premier Powered Breast Pump (Lactaline Personal) (K973501)
Device Description: The Double Electric Breast Pump (DEBP) is a powered breast pump. The pumping can be performed on one breast or on both breasts at the same time. The Lansinoh
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DEBP can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to control cycle speed and vacuum level. The Lansinoh DEBP is capable of providing vacuum levels from 50 to 250 mmHg, with cycling rates up to 1.85 cycles per second.
The DEBP is intended to express and collect the mother's milk of a Intended Use: nursing woman for the purpose of feeding the collected milk to a baby.
Performance Testing: Suction curves are provided to illustrate the performance of the DEBP. Additionally a backflow test was conducted to ensure satisfactory performance of the pump in the unlikely event that milk were to backflow into the pump unit.
The DEBP will be tested to meet:
- IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety" .
- IEC 60601-1-2:2007, "Medical electrical equipment. General requirements for basic . safety and essential performance. Collateral standard. Electromagnetic compatibility."
Substantial Equivalence: The Lansinoh DEBP is substantially equivalent to the predicate devices in intended use, technological characteristics and device design. The table below provides a comparison of the DEBP to the predicate devices.
| New Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | ENKO Ltd. | Ameda/Hollister | Medela |
| Device Name | DEBP | Expresse & PremeierBreast Pumps | Medela Swing |
| 510(k) # | not yet assigned | K973501 | K053052 |
| Intended Use | The DEBP isintended to expressand collect themother's milk of anursing woman forthe purpose offeeding the collectedmilk to a baby. | The Lactaline PersonalBreast Pumps areintended to express andcollect the mother'smilk of a nursingwoman for the purposeof feeding the collectedmilk to a baby. | The Swing BreastPump is a poweredbreast pump to be usedby lactating women toexpress and collectmilk from theirbreasts. |
| Pumping Suction | 50 - 250 mmHg | <100 - 265 mbar(<75 - 199 mmHg) | 0 - 250 mmHg |
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| Stimulation/Let DownPhase | |||
|---|---|---|---|
| Suction Levels | 50 – 150 mmHg | n/a | 0 - 250 mmHg |
| Cycles per Second | 1.85 (fixed) | n/a | up to 2.17 |
| Expression Phase | |||
| Suction Levels | 50 – 250 mmHg | <100 - 360 mbar | 0 - 250 mmHg |
| Cycles per Second | 0.51 - 1.0 | 0.5 - 1.0 | up to 2.17 |
| Suction Settings | 8 | 3 | 11 |
| Power Supply | a) 6 AA alkalinebatteriesb) AC Adapter | a) rechargeable NiCdbatteriesb) 6 AA alkalinebatteriesc) AC Adapterd) 12 V adapter for usein motor vehicle | AC Adapter |
| Pumping Option | Single or Double | Single or Double | Single |
| Back Flow Protection | Yes | Yes | No |
| Let Down Function | Yes | No | Yes |
| Cycling/Suction Control | Microcontroller | Microprocessor | Microprocessor |
1000 - 1000 :
and the comments of the comments of the comments of
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT 22 2009
ENKO Ltd. c/o Mr. Ned Devine Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096
Re: K092783
Trade/Device Name: DEBP Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: October 5, 2009 Received: October 7, 2009
Dear Mr. Devine:
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 for ass attatod in the 2001 - 76, the enactment date of the Medical Device Amendments, or to connineroo print to rialy 2008 reclance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) that 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 (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 or any I with all the Act's requirements, including, but not limited to: registration and listing Compry with an the 110 110 1 3 g (21 CFR Part 801); medical device reporting of medical
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Page 2 -
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 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,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
Forbeassigned K092783 510(k) Number: Device Name: DEBP
Indications for Use:
The DEBP is intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Hulkeum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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).