(72 days)
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Not Found
No
The summary describes a passive orthosis and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
Yes
This device is intended for the conservative treatment of various wrist conditions, providing support, immobilization, and temporary symptom relief, which are all therapeutic functions.
No
Explanation: This device is described as an orthosis used for support, immobilization, and treatment of various wrist injuries and conditions. Its function is to aid recovery and provide relief, not to identify or diagnose a condition.
No
The intended use describes an "orthosis worn on the wrist," which is a physical device, not software. The summary lacks any information about software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is an "orthosis worn on the wrist." This is a physical support device applied externally to the body.
- Intended Use: The intended uses all relate to providing physical support, immobilization, and relief of symptoms for wrist conditions. None of the uses involve analyzing biological specimens.
Therefore, this device falls under the category of a physical support or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
An orthosis worn on the wrist for medical purposes:
- to support and/or immobilize for functional improvement. .
- . for conservative treatment of s mptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
- to keep wrist motion to a minimum while worn allowing the body . to recover from the damage of repetitive motion or other injuries.
- to provide temporary relief of associated symptoms of some . wrist conditions.
Product codes
IQI
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
wrist
Indicated Patient Age Range
Not Found
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
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§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized eagle head with three horizontal lines above it, representing the agency's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2003
Mr. Christopher Crowell Quality Assurance Manager SurgiTech, Inc. 2424 Vista Way, Suite 300 Oceanside, CA 92054-6174
Re: K031576
Trade/Device Name: Spartan Orthopaedic Wrist Brace, Model SCT-1 Regulation Number: 21 CFR 890.3475 Regulation Name: Limb orthosis Regulatory Class: I Product Code: IQI Dated: June 30, 2003 Received: July 7, 2003
Dear Mr. Crowell:
We have reviewed vour 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 such 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.
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Page 2 - Mr. Christopher Crowell
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours.
Sincerely yours,
Mark N Milburn
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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3.0 Revised Statement of Indications for Use
An orthosis worn on the wrist for medical purposes:
- to support and/or immobilize for functional improvement. .
- . for conservative treatment of s mptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
- to keep wrist motion to a minimum while worn allowing the body . to recover from the damage of repetitive motion or other injuries.
- to provide temporary relief of associated symptoms of some . wrist conditions.
Mark N. Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031576
K031576 mnm
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