(136 days)
Not Found
No
The description mentions a microprocessor driving the pump and user-adjustable settings, but there is no mention of AI or ML algorithms being used for control, analysis, or adaptation.
No
The device is described as a breast pump intended to express and collect breast milk for feeding to a baby, which is not a therapeutic medical purpose.
No
Explanation: The device is a breast pump, intended to express and collect breast milk. Its function is not to diagnose any medical condition or disease.
No
The device description explicitly mentions hardware components such as a diaphragm-type vacuum pump, microprocessor, keypad, LCD display, batteries, and an AC adaptor. It is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Powered Breast Pump's intended use is to express and collect breast milk from a nursing woman. This is a physical process involving the body directly, not a test performed on a sample outside the body.
- Lack of Diagnostic Purpose: The device does not analyze the breast milk or the woman's body for any diagnostic purpose. It simply facilitates the collection of a bodily fluid.
The description clearly outlines a mechanical device for collecting breast milk, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump 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 microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Suction Curves: suction curves are provided to illustrate that the performance of the Powered Breast Pump is substantially equivalent to the predicate device.
- Back Flow Test: Additionally a backflow test was conducted to ensure satisfactory performance of the pump in the unlikely event that milk was to backflow into the pump unit.
- Cleaning Validation Study: A cleaning validation study was conducted to validate the recommended cleaning instructions for the device.
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
K122474
Page 1 of 3
Section 5: 510(k) Summary
DEC 2 8 2012
Applicant: Lansinoh Laboratories Saglik Gerecleri San. Tic. Ltd. Sti. 10006 sokak, No:64 A.O.S.B. Cigli - Izmir 35620 TURKIYE Tel: 0090 232 328 05 56/57 Fax: 0090 232 328 05 58 www.lansinoh.com.tr Attn: Halit Cahit Üstündağ
Contact: Calley Herzog Biologics Consulting Group, Inc. 13417 Quivas St. Westminster, CO 80234 Ph. 720-883-3633 Fax. 720-293-0014
| Date Summary Prepared: | 10/10/12 |
|---|---|
| Proprietary Name: | Lansinoh Powered Breast Pump |
| Common Name: | Powered Breast Pump |
| Regulatory Class: | Class II |
| Product Codes: | HGX |
| Predicate Device(s): | K092783 - Affinity Breast Pump, Lansinoh Laboratories Saglik |
| Gerecleri Tasarim San. Tic. Ltd. Sti. |
Device Description: The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump 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 microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.
1
K122474
page 2 of 3
The purpose of this Special 510(k) is for modifications to the previously cleared breast pump. The modifications are made to the cycle speeds and suction settings of the pump to create more comfortable settings for the nursing mother.
Intended Use: The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.
Performance Testing:
- l) Suction Curves suction curves are provided to illustrate that the performance of the Powered Breast Pump is substantially equivalent to the predicate device.
-
- Back Flow Test Additionally a backflow test was conducted to ensure satisfactory performance of the pump in the unlikely event that milk was to backflow into the pump unit.
-
- Cleaning Validation Study A cleaning validation study was conducted to validate the recommended cleaning instructions for the device.
Substantial Equivalence: The Powered Breast Pump is substantially equivalent to the predicate device, in intended use, technological characteristics and device design. The table below provides a comparison of the Powered Breast Pump to the predicate device.
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K122474
Page 3 of 3
:
.
:
Device Comparison Table
:
:
.
| New Device | Predicate Device | |
|---|---|---|
| Manufacturer | Lansinoh Laboratories | |
| Saglik Gerecleri Tasarim San. | ||
| Tic. Ltd. Sti. | Lansinoh Laboratories | |
| Saglik Gerecleri Tasarim San. | ||
| Tic. Ltd. Sti. | ||
| Device Name | Powered Breast Pump | Affinity Double Electric |
| Breast Pump (DEBP) | ||
| 510(k) # | K122474 | K092783 |
| Intended Use | The Powered Breast Pump is | |
| intended to express and collect | ||
| the breast milk of a nursing | ||
| woman for the purpose of | ||
| feeding the collected milk to a | ||
| baby. The Powered Breast | ||
| Pump is intended for a single | ||
| user. | The DEBP is intended to | |
| express and collect the breast | ||
| milk of a nursing woman for | ||
| the purpose of feeding the | ||
| collected milk to a baby. | ||
| Suction Levels | ||
| (stimulation) | 55 - 140 mmHg | 50 - 150 mmHg |
| Cycles per Second | ||
| (stimulation) | 1.55 - 2.4 | 1.85 (fixed) |
| Suction Levels | ||
| (expression) | 80 - 220 mmHg | 50 - 250 mmHg |
| Cycles per Second | ||
| (expression) | 0.61 - 1.52 | 0.51 - 1.0 |
| Suction Settings | 8 | 8 |
| Power Supply | a) 6 AA alkaline batteries | |
| b) AC Adapter | a) 6 AA alkaline batteries | |
| b) AC Adapter | ||
| Pumping Option | Single or Double | Single or Double |
| Back Flow Protection | Yes | Yes |
| Let Down Function | Yes | Yes |
| Cycling/Suction Control | ||
| Mechanism | Microprocessor | Microprocessor |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human figures in profile, stacked on top of each other, with their arms outstretched.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 28, 2012
Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti. % Ms. Calley Herzog Consultant Biologics Consulting Group, Inc. 13417 Quivas Street WESTMINSTER CO 80234
Re: K122474
Trade/Device Name: Powered Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: November 30, 2012 Received: December 3, 2012
Dear Ms. Herzog:
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.
4
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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.
Herbert R. Lerner
Acting Director for: 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
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.
.
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5
Section 4: Indications for Use Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Powered Breast Pump
Indications for Use:
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
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)
Herbert P. Lerner
tive, Gastro-Renal, and
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