FERRIS POLYMEM STERILE BREAST PAD

K031660 · Ferris Mfg. Corp. · NTX · Feb 22, 2005 · General Hospital

Device Facts

• Record ID: K031660
• Device Name: FERRIS POLYMEM STERILE BREAST PAD
• Applicant: Ferris Mfg. Corp.
• Product Code: NTX · General Hospital
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5630
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Over the Counter Use: To be worn inside the bra to: - Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding . - Absorb milk leakage . - Protect the nipple from abrasion and friction damage caused by bra or clothing . - Help alleviate discomfort . - Protect clothing from milk leakage .

Device Story

Ferris PolyMem® Sterile Breast Pad is a wearable absorbent dressing designed for breastfeeding women. Worn inside a bra, the pad functions as a physical barrier to protect nipples from friction and abrasion caused by clothing. It simultaneously absorbs breast milk leakage to maintain hygiene and protect garments. The device is intended for over-the-counter use by patients to soothe discomfort associated with breastfeeding-related nipple irritation or cracking.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile absorbent pad designed for placement inside a bra. Materials and specific technical standards are not detailed in the provided documentation.

Indications for Use

Indicated for breastfeeding women experiencing tender, sore, irritated, cracked, or painful nipples; intended to absorb milk leakage and protect nipples from friction/abrasion.

Regulatory Classification

Identification

A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.

Submission Summary (Full Text)

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FEB 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Newton Global Director, Product and Market Management Ferris Manufacturing Corporation 16W300 83" Street Burr Ridge, Illinois 60527-5848

Re: K031660

Trade/Device Name: Ferris PolyMem® STERILE BREAST PAD Regulation Number: 880.5630 Regulation Name: Nipple Shield Regulatory Class: I Product Code: NTX Dated: November 22, 2004 Received: November 24, 2004

Dear Mr. Newton:

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 (PMA), 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.

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Page 2 – Mr. Newton

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.

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) NUMBER (IF KNOWN): K031660

DEVICE NAME: FERRIS PolyMem® STERILE BREAST PAD

INDICATIONS FOR USE:

Over the Counter Use: To be worn inside the bra to:

- Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding .
- Absorb milk leakage .
- Protect the nipple from abrasion and friction damage caused by bra or clothing .
- Help alleviate discomfort .
- Protect clothing from milk leakage .

(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) OR

Over-the-Counter-Use (Optional Format 1-2-96)

Chm Um

Wision Sim-Off) in islon of anesthesiology. General Hospital, Intection Control. Dental Devices

709(K) number

K5 3/609