(389 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is for a standard breast pump.
No
A breast pump is generally considered a medical device, specifically for aiding in the extraction of breast milk. While it has health-related applications, it is not typically categorized as a therapeutic device in the sense of treating a disease or condition. Its primary function is collection, not therapy.
No
Explanation: This device is a breast pump, used for the extraction of breast milk. Its intended use does not involve diagnosing any medical conditions.
No
The device description explicitly states "Powered Breast Pump," indicating a hardware component is involved in the extraction of breast milk.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid nursing mothers in extracting breast milk. This is a physical process involving the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's a powered breast pump, which is a mechanical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or the breast milk itself for diagnostic purposes), image processing for diagnostic interpretation, or AI/ML for diagnostic algorithms.
- Anatomical Site: The breast is a part of the body, not a sample being analyzed.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This breast pump does not fit that description.
N/A
Intended Use / Indications for Use
The Lactation Techniques TM Model B auto cycling breast pump is to aid nursing mothers at home with the extraction of breast milk in the absence of the nursing child due to illness or other situations causing temporary separation.
Product codes
85 HGX
Device Description
Lactation Techniques™Model B Powered Breast Pump
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nursing mothers at home
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
MAY 2 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Leloudis President Lactation Techniques, Inc, 1252 West 50 South Centerville, Utah 84014
Re: K981549/S1 Lactation Techniques™Model B Powered Breast Pump Regulatory Class: II 21 CFR 884.5160/Product Code: 85 HGX Dated: March 26, 1999 Received: March 29, 1999
Dear Mr. Leloudis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indication 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission
1
Page 2 - Mr. Leloudis
does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.
David A. Szymanski, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Lactation Techniques TM Model B
Device Name:
Indications For Use:
The Lactation Techniques TM Model B auto cycling breast pump is to aid nursing mothers at home with the extraction of breast milk in the absence of the nursing child due to illness or other situations causing temporary separation.
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Jarid br. Slayton
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 1981549 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)