(89 days)
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Not Found
No
The summary describes software for surgical planning using digitized x-rays and implants, but there is no mention of AI, ML, or related concepts like image processing that might suggest their use.
No
The device is a software system intended to aid surgeons in planning orthopedic surgeries, not to directly treat or diagnose patients.
No.
The OrthoPlan System is intended for surgical planning and aids surgeons in their planning of orthopaedic surgeries, not for diagnosing medical conditions.
Yes
The device is described as a "System" that runs on a "personal computer" and "read[s] in digitized x-rays and orthopaedic implants" to aid in surgical planning. While it interacts with external data (digitized x-rays and implant information), the core functionality described is software-based processing and visualization on a standard computer platform, with no mention of dedicated hardware components included as part of the device itself.
Based on the provided information, the OrthoPlan System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "planning of orthopaedic surgeries on a personal computer" and to "aid surgeons in their planning of orthopaedic surgeries." This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Input: The input is "digitized x-rays," which are medical images, not biological specimens.
- Function: The software processes images and implant data to create constructed images for planning. It does not analyze biological samples to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The OrthoPlan System does not fit this description.
N/A
Intended Use / Indications for Use
The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.
Product codes
HWT, LNX
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
digitized x-rays
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4800 Template for clinical use.
(a)
Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.(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 § 888.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
May 14, 2024
Ortho-Graphics, Inc. Peter M. Stevens President, CEO 100 North Medical Drive, Suite 4550 Salt Lake City, Utah 84113
Re: K974406
Trade/Device Name: OrthoPlan Regulation Number: 21 CFR 888.4800 Regulation Name: Template for clinical use Regulatory Class: Class I Product Code: HWT
Dear Peter Stevens:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 1998. Specifically, FDA is updating this SE Letter as an administrative correction. A second product code was inadvertently included.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, OHT6: Office of Orthopedic Devices, 301-796-7056, Limin.Sun@fda.hhs.gov.
Sincerely.
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "US HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle above the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Peter M. Stevens, M.D. President, CEO Ortho-Graphics Inc. 100 North Medical Drive, Suite 4550 Salt Lake City, Utah 84113
K974406 Re: Trade Name: OrthoPlan Regulatory Class: II Product Codes: HWT and LNX Dated: November 15, 1997 November 21, 1997 Received:
Dear Dr. Stevens:
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 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 general controls provisions The general controls provisions of the Act 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 regulations affecting your device 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 requirement, 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 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 regulations.
2
Page 2 - Peter M. Stevens, M.D.
This letter will allow you to begin marketing your device as This letter will allow you co begin maification. The FDA described in your 510 (x) premarker notice to a legally
finding of substantial equivalence of your device for your finding of substantial equivalence of yourseification for your marketed predicate device results in a craobile to the market.
If you desire specific advice for your device on our labeling in If you desire specific advice for gotionally 809.10 for in regulation (ZI Crk rate bor unase contact the Office of vitro diagnostic devices), please contact the for questions on
Compliance at (301) 594–4659. Additionally, for questions on Compliance at (301) 394-4659. Address device, please contact
the promotion and advertising of your device, Also, please no the promotion and advertising of your ac3950 for and and and the forme of the Office of the Office of Compliance at (301) ding by reference to the regulation entification" (21 CFR 807.97). Other general premarket notification" (2) circular the Act may be information on your responsibilities andfr turers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smart Manara (301) 443–6597 or at
at its toll-free number (800) 638–2041 or (30)/dsmanin.html". at its toll-free number (800) 636-2041 of (301) 110-11-2011 11:11
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ceria M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K974406
Device Name: OrthoPlan
Indications For Use:
The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)Prescription Use X Over-The-Counter Use_ OR
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
ticollelo
(Division Sign-Off)
Division of General Restorative Devices K974406
510(k) Number