(15 days)
The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast (s) of lactating women.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the Evenflo Elan Breastpump and Evenflo Elan Dual Breastpump does not contain the specific information requested about acceptance criteria and a study proving the device meets them.
This type of FDA letter primarily focuses on:
- Substantial Equivalence Determination: Declaring that the device is substantially equivalent to a legally marketed predicate device.
- Regulatory Classification: Identifying the device's regulatory class (in this case, Class II and product code HGX).
- Applicable Regulations: Listing general controls and other relevant regulations the manufacturer must comply with.
- Indications for Use: Clearly stating the intended use of the device.
The letter does not include details about:
- Acceptance criteria table or reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- MRMC comparative effectiveness study results.
- Standalone (algorithm only) performance studies.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
These types of details would typically be found in the device's 510(k) submission itself, which is a much more extensive document than the clearance letter. The clearance letter is the FDA's summary decision, not the detailed technical review.
{0}------------------------------------------------
NOV - 1 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Evenflo Company, Inc. c/o Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K052909
Trade/Device Name: Evenflo Elan Breastpump and Evenflo Elan Dual Breastpump Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: October 13, 2005 Received: October 17, 2005
Dear Mr. Christensen:
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.
{1}------------------------------------------------
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 prarketed 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 607:37). I ou may orcums sturers, 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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): Ko5 2909
Device Name: Evenflo Elan Breast Pump
Evenflo Elan Dual Breast Pump
Indications for Use:
. . . .
The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast (s) of lactating women.
Prescription Use (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)
David h. lyons
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
§ 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).