(36 days)
No
The description focuses on the mechanical and electrical components of a standard breast pump and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
A therapeutic device is one that performs therapy, such as treating or curing a disease. A breast pump is for expressing milk, which is not a therapeutic act.
No
Explanation: A breast pump is used to express milk, which is a therapeutic or assistive function, not a diagnostic one. It does not identify or investigate any disease, condition, or state of being.
No
The device description explicitly lists hardware components such as a pump base, flexible tubing, funnel assembly, and a power supply driving a diaphragm pump.
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 milk from the breasts of a lactating woman. This is a physical process involving the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical pump that creates negative pressure to extract milk. It does not mention any components or processes related to analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes.
- Anatomical Site: The anatomical site is the breasts, which are the target of the physical action of the pump, not the source of a sample for analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This breast pump does not fit that description.
N/A
Intended Use / Indications for Use
An electrically powered breast pump with settings, for expressing milk from the breasts of a lactating woman.
An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.
Product codes
85 HGX
Device Description
The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads).
The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.
All components that may come in contact with the milk are manufactured from materials that meet FDA food contact criteria. The materials that contact the breast have been tested for biocompatibility.
The Gerber Double Electric Breast Pump is substantially equivalent to other powered breast pumps that are available for commercial distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
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
Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling.
No clinical tests have been conducted on this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the Gerber logo. The logo features a drawing of a baby's face inside a black circle. Below the circle is the word "Gerber" in a bold, sans-serif font, and below that is the text "GERBER PRODUCTS COMPANY A NON-THING OMPAN".
DEC 1 5 2004
SURE CO. DEARON L. ARRINGAN, 1971 - 198 2006 - 100 - 100 - 100 - 2004 - 100 - 100 - 100 - 100 - 100 - 100 - 100
510(k) Summary September 20, 2004
| Submitter: | Gerber Products Company
445, State Street
Fremont, MI 49413-0001
Phone: 231 928 2831
Fax: 231 928 2964 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Dr. Nicholas Hether
Director, Product Safety & Regulatory Sciences |
| Trade Name: | Gerber Double Electric Breast Pump |
| Common Name: | Electric Breast Pump |
| Classification Name: | Powered Breast Pump
21 CFR 884.5160 (85 HGX) Class-II |
| Substantial Equivalence: | The Gerber Double Electric Breast Pump is substantially
equivalent to the following legally marketed predicate devices: |
| Company | Product Name | 510(k) clearance# |
|---|---|---|
| Medela | Pump-in-Style | K031614 |
| Ameda Egnell | Purely Yours | K973501 |
| Playtex | Breast Pump | K022594 |
General Description:
The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads).
Device Description:
The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.
1
Design and materials:
All components that may come in contact with the milk are manufactured from materials that meet FDA food contact criteria. The materials that contact the breast have been tested for biocompatibility.
Intended Use:
An electrically powered breast pump with settings, for expressing milk from the breasts of a lactating woman.
Technological Characteristics of the Device:
The Gerber Double Electric Breast Pump is substantially equivalent to other powered breast pumps that are available for commercial distribution. A chart showing the similarities and differences of the proposed powered breast pump and the predicate powered breast pumps follows:
| Comparison of Predicate Devices | ||||||
|---|---|---|---|---|---|---|
| New device | K031614 | K022594 | K973501 | |||
| Gerber | ||||||
| DoubleElectric | ||||||
| Breast Pump | Medela | |||||
| Pump-in-Style | Playtex Breast | |||||
| Pump | Ameda Egnell | |||||
| Purely Yours | ||||||
| Intended Use: | Express milk | Express milk | Express milk | Express milk | ||
| Power Source: | DC | DC | DC | DC | ||
| Pump Style: | Diaphragm | Diaphragm | Reciprocating | |||
| Piston | Reciprocating | |||||
| Piston | ||||||
| Single/double Pumping: | Both | Both | Both | Both | ||
| Adjustable Suction | ||||||
| Levels: | Yes | Yes | Yes | Yes | ||
| Cycle Speed: | Fixed | Variable | Variable | Variable | ||
| Overflow Protection: | No | No | Yes | Yes | ||
| Highest Vacuum Setting |
- (mmHg): | 240 | 250 | 229 | 170 | | |
| Lowest Vacuum Setting | 0 | 0 | 64 | 31 | | |
| Active Breast Massage: | Yes | No | Yes | No | | |
| Software (microchip) | Yes | Yes | Yes | Yes | | |
Discussion of Non-clinical Tests:
Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling.
Discussion of clinical tests performed:
No clinical tests have been conducted on this device.
Conclusion:
The Gerber Double Electric Breast Pump is safe and effective for its intended use of milk expression and is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Gerber Products Company % Ms. Chantel Carson Manager Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K043098
Trade/Device Name: Gerber Double Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: November 24, 2004 Received: November 30, 2004
Dear Ms. Carson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
K_043098 ___ (To be assigned)
Device Name:
Gerber Double Electric Breast Pump
Indications for Use:
An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.
Prescription Use (Per CFR 801.109)
or
Over-the-counter use
. ಇ
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leymann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number