(260 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The intended use and device description suggest a simple heating device.
Yes
The device is intended to provide temporary relief of minor aches and pains, aid in muscle relaxation, improve range of motion, and increase local blood circulation, which are therapeutic benefits.
No
Explanation: The "Intended Use / Indications for Use" section describes the device providing temporary relief, relaxation, and increased circulation for comfort and pain relief. There is no mention of the device being used to diagnose any condition or disease.
No
The provided 510(k) summary lacks sufficient information to determine if the device is software-only. The "Device Description" is simply "BioPack," and there is no mention of software, hardware, or how the intended uses are achieved. The description of the device is entirely absent.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes providing temporary relief of pain, muscle relaxation, improved range of motion, and increased blood circulation. These are all therapeutic or comfort-related applications, not diagnostic testing performed on samples taken from the body.
- Device Description: "BioPack" is a generic term and doesn't suggest a device used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue), performing tests, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The description provided clearly indicates a device used for external application for therapeutic or comfort benefits.
N/A
Intended Use / Indications for Use
- Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional
- Provides temporary relief of minor aches and pains in muscles and joints
- Aids in the relaxation of muscles
- Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
- Provides a temporary increase in local blood circulation
Product codes
ILY
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
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with three horizontal lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2000
Butch Smith, Vice President BioScan, Inc. 6 Walden Road Corrales, New Mexico 87048
Re: K993685 and K993686 Trade Name: BioPack and Light Patch Regulatory Class: II Product Code: ILY Dated: April 5, 2000 Received: April 19, 2000
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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.
1
Page 2 - Butch Smith
This letter will allow you to begin marketing your devices as described in your 510(k) premarket I mis letter will anow you to ocgin mantany i equivalence of your devices to legally marketed notifications. The PDF Imaling of sassion for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and If you desire specific acres in the other ostic devices), please contact the Office of Compliance at additionally 607.10 101 = 10 = 10 = 10 = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 (301) 594-1057. Traditionally, and the 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 mormation on your responsive 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,
Dwine R. bochner
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K993685
Device Name: BioPack
Indications for Use:
-
Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional
- Provides temporary relief of minor aches and pains in muscles and joints 公
-
Aids in the relaxation of muscles
-
Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
-
Provides a temporary increase in local blood circulation
(PLEASE DO NOT WITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR
Over the Counter Use:
(Optional Format 1-2-96)
Dmane R. Vochra.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number K9936 85