(111 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The description focuses solely on a surgical system for bunion correction.
Yes
The device is described as assisting in the biomechanical reduction of abnormal intermetatarsal angle and correction of Hallux Valgus deformities, indicating it treats or alleviates a condition.
No
The device is described as a "Bunion Correction System" intended to "assist in the biomechanical reduction of abnormal intermetatarsal angle" and "assist in the correction of Hallux Valgus deformities." This indicates it is a surgical system designed for treatment, not for diagnosis.
No
The 510(k) summary describes a "Bunion Correction System" intended for surgical indications related to biomechanical reduction and correction of Hallux Valgus deformities. This strongly implies a physical device used in surgery, not a software-only product. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, the Instratek HAV-Lok Bunion Correction System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for surgical indications to assist in the biomechanical reduction and correction of Hallux Valgus deformities. This involves a surgical procedure performed on a patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on the analysis of these samples.
- Performing tests in a laboratory setting.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Instratek HAV-Lok Bunion Correction System is a surgical device used during a surgical procedure on a patient's foot.
N/A
Intended Use / Indications for Use
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications:\n\n- . To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.
Product codes
HTN
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
Prescription Use (Part 21 CFR 801 Subpart D)
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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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K082384 (pg 1/2)
Traditional 510(k)
SECTION 5. 510(K) SUMMARY
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Page 12 of 76
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KOB2384 (pg 212)
the
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| HAV-Lok Bunion Correction System | Traditional 510(k) |
|---|---|
| Intended use of the device: | The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: |
| To assist in the biomechanical reduction of abnormal intermetatarsal angle. | |
| Technological characteristics: | The technological characteristics between the predicate and proposed devices are the same. |
| Conclusions: | There are no significant differences between the proposed and predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness. |
The HAV-Lok Bunion Correction System, as designed, is as safe and effective as the predicate devices. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market. |
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Page 13 of 76
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 8 2008
Instratek Inc. % Mr. Jeff Seavey 210 Springhill Drive Suite 130 Spring, Texas 77386
Re: K082384
Trade/Device Name: HAV-Lok Bunion Correction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: November 18, 2008 Received: November 18, 2008
Dear Mr. Seavey:
We have reviewed your 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 101 ass bared in the 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, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controll proficituring 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 If your device is elaborned too words. 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 r tease of acrised a determination that your device complies with other requirements of the Act that I Drimas made a aved regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (DS) 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. Jeff Seavev
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indications for Use:
KD82384 (pg 111)
HAV-Lok Bunion Correction System
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications:
- . To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) · Concurrence of CDRH, Office of Device Evaluation (ODE)
Nerf he. Ryden for mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K0