(260 days)
- 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
BioPack
This document is a 510(k) clearance letter from the FDA for a device called "BioPack" (and "Light Patch", though the section provided focuses on BioPack). It primarily addresses the regulatory approval process and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria.
Therefore, most of the requested information cannot be extracted from the provided text. The document is a regulatory approval notice, not a clinical study report or a technical specification document.
Here's what can be inferred or stated based on the given text:
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A table of acceptance criteria and the reported device performance: This information is not present in the document. The FDA letter confirms substantial equivalence to a predicate device, but does not detail specific performance metrics or acceptance criteria met by the BioPack itself.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available in the provided text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The BioPack is described as a hot application device for therapeutic use, not an AI-assisted diagnostic or interpretative device that would involve human readers or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device. The BioPack is a physical therapeutic device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in the provided text. Given the device's indications for use (minor aches and pains, muscle relaxation, local blood circulation), ground truth would likely be established through clinical outcomes, patient-reported symptoms, or physiological measurements, but the document does not specify.
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The sample size for the training set: Not applicable and not available. This device is not an AI/ML algorithm that would have a "training set."
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How the ground truth for the training set was established: Not applicable and not available.
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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.
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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
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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
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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
§ 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.