(14 days)
Not Found
No
The 510(k) summary describes a mechanical interference screw and explicitly states that AI, DNN, or ML were not found in the document.
No.
The device is an interference screw used for fixation of soft tissue grafts in ACL reconstruction, which is a surgical implant rather than a device designed to deliver therapeutic treatment in itself.
No
The device is described as an interference screw used for fixation of soft tissue grafts in ACL reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, resorbable screw, which is a hardware component, 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 fix tissue, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "resorbable, cannulated, interference screw" with specific physical characteristics and sizes. This is consistent with a surgical device, not an IVD.
- 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 those samples
- Providing diagnostic information about a patient's health status
Therefore, the Phantom SofThread Soft Tissue Interference Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Phantom SofThread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction. The Phantom SofThread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
87 HWC, MAI
Device Description
The modified Phantom SofThread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The SofThread Screw is available in four diameters (7, 8, 9 and 10mm) in one 25mm length. The modified Phantom SofThread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
AUG 3 | 1998
SPECIAL 510(k) DEVICE MODIFICATION PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF SPONSOR: | DePuy®, Inc.
P.O. Box 988
Warsaw, Indiana 46581-0988 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Sally Foust
Senior Regulatory Submissions Associate
DePuy Orthopaedics, Inc.
1 (219) 372-7455; FAX: 1 (219) 267-7098
E-Mail: Sally_Foust@ccgate.depuy.com |
| TRADE NAME: | Phantom™ SofThread Soft Tissue Interference Screw |
| COMMON NAME: | Interference Screw |
| CLASSIFICATION: | 888.3040 - Smooth or threaded bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
SUBSTANTIALLY EQUIVALENT DEVICE:
Phantom SofThread Soft Tissue Interference Screw (K980440)
DEVICE DESCRIPTION AND INTENDED USE:
The modified Phantom SofThread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The SofThread Screw is available in four diameters (7, 8, 9 and 10mm) in one 25mm length. The modified Phantom SofThread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The fundamental scientific technology of the modified Phantom SofThread Screw has not changed from the FDA cleared (K980440) Phantom SofThread Screw. The intended use of the modified Phantom SofThread Screw as described in its labeling has not changed from the FDA cleared (K980440) Phantom SofThread Screw. With the exception of minor design modifications (i.e., rounded head; increased broach depth, nose diameter and minor diameter, and slightly reduced thread pitch) the modified Phantom SofThread Screw is identical to the FDA cleared (K980440) Phantom SofThread Screw.
Based on conformance with the design control procedures requirements as specified in 21 CFR 820.30, similarities of design, identical materials and intended use, DePuy believes that the modified Phantom SofThread Screw is substantially equivalent to the FDA cleared K980440) Phantom SofThread Screw.
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1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1998
Ms. Sally Foust Senior Requlatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive 46581-0988 Warsaw, Indiana
Re: K982900 Phantom™ SoftThread Soft Trade Name: Tissue Interference Screw Regulatory Class: II Product Codes: MAI and HWC Dated: August 14, 1998 August 17, 1998 Received:
Dear Ms. Foust:
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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 - Ms. Sally Foust
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.
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 ene regaration onestica, "MisFidian" (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. ia M. Witten, Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) ८ ९ 2
Device Name: Phantom SofThread Soft Tissue Interference Screw
Indications for Use:
The Phantom SofThread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
8/27/98
Concurrence of CDRH, Office of Device Evaluation
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(Division Sign-Off)
Division of General Restorative Devices 510(k) Number .
Prescription Use_ OR X (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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