(58 days)
No
The summary describes a mechanical implant (screw) and its performance in mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an "interference screw" used for "fixation of soft tissue grafts in ACL reconstruction," which indicates a therapeutic purpose to aid in healing and restoration of function.
No
The device is an orthopedic implant (interference screw) used for fixation in ACL reconstruction, which is a treatment, not a diagnostic process. The description focuses on its mechanical properties and intended use in surgery.
No
The device description clearly describes a physical, resorbable screw made of material, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide interference fixation of soft tissue grafts in ACL reconstruction." This describes a surgical implant used within the body to support tissue, not a test performed outside the body on biological samples to diagnose or monitor a condition.
- Device Description: The description details a "resorbable, cannulated, interference screw" with specific physical characteristics and dimensions. This is consistent with a surgical implant.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Phantom Sof-Thread Soft Tissue Interference Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Phantom Sof-Thread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
The Phantom Sof-Thread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
Product codes
87 HWC, MAI
Device Description
The Phantom Sof-Thread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The Sof-Thread Screw is available in 4 diameters, 7, 8, 9 and 10mm, and one length, 25mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Phantom Sof-Thread Screw are comparable to those of the Linvatec BioScrew.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy Hyloc Interference Screw, K955733
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
APR - 3 1998
| NAME OF SPONSOR: | DePuy Inc.
P.O. Box 988
Warsaw, Indiana 46581-0988 |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Regulatory Submissions |
| TRADE NAME: | DePuy OrthoTech Phantom™ Sof-Thread Soft Tissue
Interference Screw |
| COMMON NAME: | Interference Screw |
| CLASSIFICATION: | 888.3040 Smooth or threaded bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Hyloc Interference Screw, K955733
Linvatec BioScrew Absorbable Interference Screw. |
DEVICE DESCRIPTION AND INTENDED USE:
The Phantom Sof-Thread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The Sof-Thread Screw is available in 4 diameters, 7. 8, 9 and 10mm, and one length, 25mm. The Phantom Sof-Thread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Hyloc Interference Screw (now called the Phantom Interference Screw) is a resorbable, cannulated or non-cannulated interference screw, manufactured from the same material as the Phantom Sof-Thread Screw (PLLA), available in diameters of 7, 8 and 9mm and in lengths of 15-30mm. It is intended to be used to provide interference fixation of the bone block in bonetendon-bone grafts used for ACL reconstruction. The major differences in design between the Phantom Sof-Thread Screw and the Phantom Interference Screw are the more rounded and widely spaced threads, the rounded edges on the driver end and the one larger diameter size of the Phantom Sof-Thread Screw.
The Linvatec BioScrew Absorbable Interference Screw is a resorbable, cannulated interference screw available in diameters of 7-9mm and lengths of 20-30mm. The BioScrew is manufactured from PLLA and is intended "to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction and for femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semitendinous, gracilis)".
Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Phantom Sof-Thread Screw are comparable to those of the Linvatec BioScrew.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Ms. Cheryl Hastings Manager, Regulatory Submissions DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive Warsaw, Indiana 46581-0988
Re: K980440
Trade Name: Phantom™ Sof-Thread Soft Tissue Interference Screw Regulatory Class: II Product Code: HWC and MAI Dated: February 3, 1998 Received: February 4, 1998
Dear Ms. Hastings:
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 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 (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 (OS) 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 ... 124 mm 17 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.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Cheryl Hastings
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
sincerely yours,
a 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
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name Phantom Sof-Thread Soft Tissue Interference Screw
Indications for Use:
The Phantom Sof-Thread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation
| Prescription Use
| (Per 21 CFR 801.100) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980440 |
|---|---|
| --------------- | --------- |
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