(84 days)
Not Found
Not Found
No
The device description explicitly states it is a "non-powered, hand-operated (piston-type) suction device" and there are no mentions of AI, ML, or related concepts in the provided text.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is explicitly described as a "suction device used to express milk from the breast of lactating women," which is a physiological process, not a medical treatment.
No
The device is described as a "suction device used to express milk from the breast of lactating women," which is a functional purpose, not a diagnostic one.
No
The device description explicitly states it is a "non-powered, hand-operated (piston-type) suction device," which is a physical hardware device, 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 "express milk from the breast of lactating women." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description confirms it's a "non-powered, hand-operated (piston-type) suction device." This aligns with a physical device for expressing milk, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, this device falls under the category of a medical device used for a physical function, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Like the predicate device, the proposed Evenflo Comfort Ease Manual Breast Pump is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
Product codes
85 HGY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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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
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Mr. Matthew McCarty Product Safety Engineer Evenflo Company, Inc. 707 Crossroads Court VANDALIA OH 45377 Re: K013226
Trade/Device Name: Evenflo Comfort Ease Manual Breast Pump Kit Regulation Number: 21 CFR 884.5150 Regulation Name: Nonpowered breast pump Regulatory Class: II Product Code: 85 HGY Dated: September 26, 2001 Received: September 27, 2001
Dear Mr. McCarty:
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 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 510(k) premarket This letter will anow you to ovejn marketing , quivalence of your device to a legally marketed nouthcation. The I Dri miding of baction 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 II you desire specific advice for your de of the following numbers, based on the regulation number at the top of this 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 Additionally, for questions on also, please note the regulation entitled, "Misbranding Office of Compilance at (2017 37) - 1097 (21 CFR Part 807.97). Other general information on by reletence to premation (2) - St may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer of 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_1_of_1_
510(k) Number (if known):__K01322323 Evenflo Device Name: Lonfort Ease Manual Breast Pump
Indications For Use:
ions For Use:
Like the predicate device, the proposed Eventlo Comfort East Pump .
Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device
used to express milk from the breast of lactating women.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use ✓ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013226 |