(440 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is a standard medical device (compression pump).
Yes
The device is indicated for treating medical conditions such as edema, lymphedema, and venous stasis ulcers, which directly relate to health intervention and management.
No
The device is described as a "Compression Pump" with indications for conditions like edema and ulcers, which suggests a therapeutic rather than a diagnostic function. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description explicitly states "Compression Pump, Model 651," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the "Compression Pump, Model 651" clearly indicate it is a physical therapy or medical device used externally on the body to treat conditions like edema and ulcers. It does not involve testing samples taken from the body.
- Lack of IVD-Related Information: The provided information lacks any mention of biological samples, testing, analysis of bodily fluids, or any other characteristics typically associated with IVD devices.
Therefore, this device falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Common Indications
Peripheral edema
Lymphedema (Postmastectomy, congenital)
Venous Stasis Ulcers
Stump reduction
Hand edema
Product codes
JOW
Device Description
Compression Pump, Model 651
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand edema (inferred from indications)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.
5 1998 AUG
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Donahue President Biomedical Horizons, Inc. P.O. Box 889 1331 Horton Road Jackson, MI 49204
Re : K971892 Biomedical Horizons Compression Pump, Model 651 Regulatory Class: II Product Code: JOW Dated: May 19, 1998 Received: May 20, 1998
Dear Mr. Donahue:
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 indications for use stated in the enclosure) to leqally 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 qeneral 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 requlations.
1
Page 2 - Mr. William J. Donahue
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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Page 1 of 1
K971892 510(k) Number (il known):
Compression Pump, Model 651 Device Name: Biomedical Horizons, Inc.
Indications For Use:
Common Indications
Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Stump reduction Hand edema
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bese E. Kemper Q
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
Kazi892 510(k) Number_
Prescription Use_سي_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)