K Number
K052858
Device Name
SOOTHIES GEL PADS
Manufacturer
Date Cleared
2006-02-09

(121 days)

Product Code
Regulation Number
880.5630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.
Device Description
Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.
More Information

Not Found

No
The description focuses on the physical properties and function of a gel pad, with no mention of AI or ML.

Yes
The device is intended to provide relief for sore and/or cracked nipples and cool painful nipples, which constitutes a therapeutic effect.

No

Explanation: The device description and intended use clearly state that Soothies Gel Pads are designed for protection, relief, and comfort (preventing friction, providing relief for sore nipples, cooling sensation). There is no mention of the device being used to identify, detect, monitor, or diagnose any medical condition, disease, or abnormal state.

No

The device description explicitly states it is composed of physical materials (glycerin, water, polyacrylamide, cloth backing) and is a physical nipple shield, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to prevent friction, provide relief for sore/cracked nipples, and act as an absorbent and protective nipple shield. This is a direct physical interaction with the body for therapeutic and protective purposes.
  • Device Description: The device is a physical pad applied to the nipple. Its composition and function are related to providing a physical barrier, cooling, and absorption.
  • Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Soothies Gel Pads do not fit this description.

N/A

Intended Use / Indications for Use

Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.

Product codes

NXH

Device Description

Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nipple

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Soothies and ElastoGel Occlusive Gel, Ameda Comfort Gel Hydrogel Pads, Breast Therapy Soothing® Gel Patches

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.5630 Nipple shield.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

0

Section 5

2006 FEB 9

510(k) Summary

Soothies

Contact Person: Ms. Leslie Sebastian Title: President and CEO Address: 9853 Pacific Heights Boulevard; Suite L; San Diego, CA 92121 Phone: (858) 228-1660 Fax: (858) 228-1650 Email: Leslies@soothies.com Establishment Registration Number: Pending Regulation Number: Classification: 880.5630 Device Class: 1 Common Name, Device: Nipple Shield Regulation Medical Specialty: General Hospital Review Panel: General Hospital

Intended Use

Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.

Description of Device

Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.

1

KC52858

Predicate Devices

Soothies and ElastoGel Occlusive Gel are substantially equivalent because they are made of the same material.

Soothies are also substantially equivalent to the Ameda Comfort Gel Hydrogel Pads and the Breast Therapy Soothing Gel Patches because they have the:

  • Same intended use 제
  • . Same indicated target population
  • . Same environment of use, and
  • Same or similar design "

Safety

The differences between Soothies and its predicate devices do not adversely affect the safety or effectiveness of the product. Although Soothies, the Ameda Comfort Gel Hydrogel Pads, and the Breast Therapy Soothing® Gel Patches contain some different materials, as described below, numerous studies have demonstrated the safety of Soothies.

Puronyx has had the safety of Soothies studied for any potential health risk to a nursing infant and mother attributable to acrylamide monomer in the acrylamide polymer gel component of Soothies. The evaluation assumes that a residue of acrylamide gel is present on the mother's breast following her use of the pad and is subsequently ingested by the infant. The evaluation demonstrates that the heath risks to a nursing infant and an adult woman using the pads are de minimis.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 9

Ms. Leslies Sebastian President and CEO Puronxy, Incorporated 9853 Pacific Heights Boulevard, Suite L San Diego, California 92121

Re: K052858

Trade/Device Name: Smoothies® Gel Pads Regulation Number: 880.5630 Regulation Name: Nipple Shield Regulatory Class: I Product Code: NXH Dated: January 25, 2006 Received: January 26, 2006

Dear Ms. Sebastian:

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 promarket 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.

3

Page 2 - Ms. Sebastian

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/industry/support/index.html.

Sincerely yours,

Sylvia y. Michael Oms

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

4

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Indications for Use

510(k) Number (if known): K052828

Device Name: Soothics® Gcl Pads

Indications for Use:

Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples.

Prescription Use Frescription Ose
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim
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Ancy, Ceneral Hospital,

K452658