(124 days)
Not Found
No
The device description details a simple electrically powered breast pump with pre-set speed and suction settings controlled by a dial. There is no mention of AI, ML, image processing, or any adaptive or learning capabilities. The performance studies section also does not indicate any AI/ML-related testing or metrics.
No
Explanation: A breast pump facilitates a natural bodily function (milk expression) and is not intended to treat or cure a disease or condition. Therapeutic devices generally aim to restore, modify, or provide therapy for a specific medical condition.
No
The device is described as an electrically powered breast pump used to express milk. Its function is to collect milk, not to diagnose any condition or disease.
No
The device description clearly outlines hardware components such as a pump assembly, breast cup assembly, and a 12V DC power supply, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The described device is an electric breast pump. Its function is to physically express milk from a lactating woman's breast. It does not analyze any biological specimens to provide diagnostic information.
- Intended Use: The intended use is clearly stated as "to express milk from the breast of a lactating woman." This is a mechanical function, not a diagnostic one.
The information provided about the device's description, power source, controls, and testing all relate to its mechanical operation and safety, not to any diagnostic capabilities.
N/A
Intended Use / Indications for Use
The intended use of the Playtex Embrace Petite Breast Pump is to express milk from the breast of lactating women.
An electrically powered breast pump used to express milk from the breast of a lactating woman.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 3 major assemblies: a pump assembly, a breast cup assembly, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 1 pre-set speed level and 3 pre-set suction setings, which are selectable by the user via a rotating dial. The device is powered by a 12V DC power supply, which is included with the package.
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
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)
Discussion of Non-Clinical Tests: Testing of the device has demonstrated that the Playtex 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.
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
AUG 1 2006
Playtex
Technical Center 75 Commerce Drive Allendale, New Jersey 07401-1600 201 785-8000
Playtex Products, Inc.
510(k) Summary of Safety and Effectiveness
March 27, 2006
Submitter:
Playtex Products, Inc. 75 Commerce Drive Allendale, NJ 07401 Phone: 201-785-8000
| Contact Name: | Karin Jordan
Senior Regulatory Affairs and Compliance Manager | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------|
| Trade name: | Playtex Embrace Petite Double Electric Breast Pump | |
| Common name: | Powered Breast Pump for Mother's Milk | |
| Classification name: | Powered Breast Pump, 21 CFR 884.5160 (85 HGX) Class II | |
| Substantial Equivalence: | Playtex Breast Pump is substantially equivalent to the following
currently marketed breast pumps: | |
| Company | Product Name | 510(k) Clearance Number |
| Playtex Products, Inc.
Ameda Egnell
Medela | Embrace
Elite
Pump-in-Style | K022594
K950531
K950750 |
The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 3 major assemblies: a pump assembly, a breast cup assembly, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 1 pre-set speed level and 3 pre-set suction setings, which are selectable by the user via a rotating dial. The device is powered by a 12V DC power supply, which is included with the package.
| 8: 2
1
Kobe013
Design and Materials:
All milk and human contact components are manufactured from materials that meets FDA food additive criteria as set forth in Part 21 Code of Federal Regulations Parts 176, 177 and 178. In addition, the silicone breast cup insert has been tested for biocompatibility per established guidelines. These items have been previously approved under 510(k) #K022594.
Intended Use:
The intended use of the Playtex Embrace Petite Breast Pump is to express milk from the breast of lactating women.
Comparison to Predicate Devices
The following is a chart showing the similarities and differences between the Playtex Breast Pump and the Predicate Devices:
| | Playtex
Embrace
Petite Breast
Pump | Playtex
Embrace
Breast Pump | Medela Pump-
in-Style | Ameda Purely
Yours |
|---------------------------------------|---------------------------------------------|-----------------------------------|----------------------------|--------------------------------------------------------|
| 510(k) Number | N/A | K022594 | K950750 | K973501 |
| Intended Use | To Express
Milk | To Express
Milk | To Express Milk | To Express Milk |
| Power Source | DC Power
Supply | DC Power
Supply | DC Power
Supply | DC Power Supply
or 6 AA Batteries |
| Pump Type | Reciprocating
Piston | Reciprocating
Piston | Reciprocating
Diaphragm | Reciprocating
Piston |
| Single or Double Pumping | Both | Both | Both | Both |
| Adjustable Suction Levels | Yes | Yes | Yes | Yes |
| Adjustable Cycle Speed | No | Yes | Yes | Yes |
| Overflow Protection | Yes | Yes | No | Yes |
| Highest Vacuum Setting (in
Hg) | 8.4 | 9.0 | 7.2 | 6.4 |
| Lowest Vacuum Setting (in
Hg) | 2.8 | 3.1 | 3.8 | 0.8 |
| Range of Cycle Speeds
(Cycles/min) | 45 | 57-40 | 66-41 | 67-29 |
| Breast Cup-to-Breast Interface | Soft Silicone | Soft Silicone | Rigid Plastic | Rigid Plastic
(partial silicone
covering avail.) |
| Active Breast Massage | Yes | Yes | No | No |
Discussion of Non-Clinical Tests:
Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling.
2
Discussion of Clinical Tests Performed:
No clinical tests have been conducted on this device.
Conclusion:
In conclusion, the Playtex Embrace Petite Breast Pump is substantially equivalent to its predicate devices. Based upon the test data submitted, the device provides sufficient vacuum pressure to effectively and safely express and collect milk from lactating women.
3
Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird with three curved lines forming its body and wings. The overall design is simple and conveys a sense of official authority.
Food and Drug Administration 9200 Corporate Blyd. Rockville MD 20850
AUG 1 5 2006
Ms. Karin E. Jordan Senior Regulatory Affairs and Compliance Manager Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401
Re: K061013
Trade/Device Name: Playtex® Petite Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 6, 2006 Received: July 7, 2006
Dear Ms. Jordan:
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.
Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large "FDA" in bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
4
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of our device complies with other requirements of the Act that IDA has made a delerimiation administered by other Federal agencies. You must or ally if edelal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, more 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 801), good manager and 820); and f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceing your antial equivalence of your device to a legally premarket nothleadon: "The PDF Intellig of easing 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 If you desire specific article for your do the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prease note the regulation chared, information on your responsibilities under (21CFK Fall 807.97). 10d may other generalisms and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.litml.
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
5
Indications for Use Statement
Page 1 of 1
| Applicant: | Playtex Products, Inc. |
|---|---|
| 510(k) Number (if known): | K061013 |
| Device Name: | Playtex® Petite Breast Pump |
| Indications for Use: | An electrically powered breast pump used to express milk from the breast of a lactating woman. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional format 1-26-99)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .