(42 days)
Not Found
No
The description details a microcontroller-controlled electric motor and user-controlled settings (cycle speed, vacuum level). There is no mention of AI, ML, or any learning or adaptive capabilities based on data.
No.
The device is intended to express and collect breast milk, which is a supportive function for feeding a baby, not a therapeutic treatment for a disease or condition.
No
The device is described as a "Double Electric Breast Pump" used to express and collect milk. Its intended use does not involve diagnosing any medical conditions, but rather a mechanical process of milk extraction.
No
The device description explicitly details hardware components such as a diaphragm-type vacuum pump, DC electric motor, keypad, and LCD display, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby." This is a physical process of collecting a biological sample (milk) for direct use (feeding), not for diagnostic testing or analysis of the sample itself.
- Device Description: The description details a mechanical pump designed to create vacuum for milk expression. It does not mention any components or functions related to analyzing or testing the milk.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (like milk, blood, urine, etc.)
- Providing diagnostic information
- Using reagents or test kits
- Measuring analytes or biomarkers
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health or condition. This breast pump's function is purely for collection.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Nursing woman / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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 & Premeier | |
| Breast Pumps | Medela Swing | ||
| 510(k) # | not yet assigned | K973501 | K053052 |
| Intended 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. | The Lactaline Personal | ||
| Breast Pumps are | |||
| 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 Swing Breast | ||
| Pump is a powered | |||
| breast pump to be used | |||
| by lactating women to | |||
| express and collect | |||
| milk from their | |||
| breasts. | |||
| Pumping Suction | 50 - 250 mmHg |