(207 days)
Non-powered Breast Pump to express milk from the breast.
Easy Comfort ™ Deluxe Manual Breast Pump
This document is a 510(k) premarket notification letter from the FDA for a nonpowered breast pump. It does not include information about acceptance criteria or a study proving device performance in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).
Therefore, I cannot extract the requested information from this document. The document primarily focuses on:
- Device Identification: Easy Comfort™ Deluxe Manual Breast Pump, Regulation Number 21 CFR 884.5150 (Nonpowered breast pump).
- Regulatory Determination: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
- General Controls: Reference to general controls provisions of the Act (registration, labeling, good manufacturing practice, etc.).
- FDA Contact Information: For questions regarding labeling, promotion, and general responsibilities.
- Indications for Use: "Non-powered Breast Pump to express milk from the breast."
There is no mention of "acceptance criteria" for performance, specific metrics like sensitivity or specificity, or details of any clinical or performance study conducted to establish these.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 5 2004
Mr. Robin C. Conner Quality Assurance Manager The First Years, Inc. Corporate Headquarters One Kiddie Drive AVON MA 02322-1171
Re: K032845
Trade/Device Name: Easy Comfort™ Deluxe Manual Breast Pump Regulation Number: 21 CFR 884.5150 Regulation Name: Nonpowered breast pump Regulatory Class: II Product Code: 85 HGY Dated: January 22, 2004 Received: January 23, 2004
Dear Mr. Conner:
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.
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 CFF) 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,
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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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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
Page 2
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ATTACHMENT 3
INDICATIONS FOR USE STATEMENT
022845 510(k) Number (if known): _
Easy Comfort ™ Deluxe Manual Breast Pump Device Name:
Indications for Use:
Non-powered Breast Pump to express milk from the breast.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. brogdon
(Division Sign-Off)
Over-The-Counter Use
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032845
p. 13 of 15
§ 884.5150 Nonpowered breast pump.
(a)
Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.