(177 days)
No
The description focuses on the physical characteristics and material of a surgical screw, with no mention of AI or ML capabilities.
No
The device is a screw used for fixation of grafts during ACL/PCL reconstruction, which is a structural component for stability rather than directly treating a disease or condition.
No
The device is described as a screw used for fixation during ligament reconstruction, which is a therapeutic intervention, not a diagnostic process.
No
The device description clearly states it is a physical screw made of polylactic acid, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical screw made of polylactic acid, designed for implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not interact with biological specimens in this way.
The BioRCI Screw is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The BioRCI Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Indications:
(Per 21 CFR 801.109)
- The BioRCI Screw is used for fixation of bone-tendon-bone or soft-tissue . grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Product codes
87HWC
Device Description
The BioRCI Screw is a screw that has a range of diameters from 7 to 10 mm and a length that ranges from 25 mm to 35 mm. The material of construction for both the BioRCI and the Bioabsorbable Interference screws is polylactic acid.
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)
The BioRCI Screw has been tested against the RCI Fixation Screw. Both screws had results that are recorded in the test results located in attachment one.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
'JAN 1 2 2000
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFFR §807.92.
The assigned 510(k) number is :
This summary was prepared on July 16, 1999
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
B. Company Contact
Demetrios Tsakonas Clinical/Regulatory Specialist
C. Device Name
Trade Name: BioRCI Screw Common Name: Screw, Fixation, Bone, Orthopedics Classification Name: Screw: 87HWC
D. Predicate/Legally Marketed Devices
RCI Fixation Screws Smith & Nephew, Inc. (K980841, 5/20/98) Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
Bioabsorbable Interference Screw Smith & Nephew, Inc (K984320, 1/20/99) Endoscopy Division 130 Forbes Boulevard Mansfield, MA 020487
1
E. Device Description
The BioRCI Screw is a screw that has a range of diameters from 7 to 10 mm and a length that ranges from 25 mm to 35 mm. The RCI Fixation Interference Screw is provided in a range of diameters from 7 to 9 mm and a range of lengths from 25 to 50 mm. The Bioabsorbable Interference Screw is provided in a range of diameters from 7 to 9 mm and a length that ranges from 20 mm to 30 mm. The material of construction for both the BioRCI and the Bioabsorbable Interference screws is polylactic acid.
Performance F.
The BioRCI Screw has been tested against the RCI Fixation Screw. Both screws had results that are recorded in the test results located in attachment one.
G. Intended Use
The BioRCI Screw has the same intended use as both the RCI Fixation Screw and the Smith & Nephew Bioabsorbable Interference screws. The RCI Fixation screw is used for fixation of bone-tendon-bone grafts or softtissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction. The Smith & Nephew Bioabsorbable Interference is used for fixation of bone-tendon-bone grafts or soft-tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction.
H. Substantial Equivalence
The BioRCI Screw , RCI Fixation Screw, and the Bioabsorbable Interference Screw have similar designs. These screws are used in fixating grafts to bone. The material for the Bioabsorbable Interference Screws and the BioRCI screws are the same and the screws have similar dimensions.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.
2
A summary comparison of the characteristics of the BioRCI Screw and the substantially equivalent devices is presented in the
| Attribute | Current Product | Substantially Equivalent Product | Substantially Equivalent Product |
|---|---|---|---|
| Indication | BioRCI Screw | RCI Fixation Screw | Smith & Nephew Bioabsorbable Interference Screw |
| Bone-Tendon-Bone or Soft Tissue Graft Fixation for ACL/PCL Reconstruction | Bone-Tendon-Bone or Soft Tissue Graft Fixation for ACL/PCL Reconstruction | Bone-Tendon-Bone or Soft Tissue Graft Fixation for ACL/PCL Reconstruction | |
| Dimensions | Diameter: 7 - 10 mm | ||
| Length: 25 - 35 mm | Diameter: 7 - 9 mm | ||
| Length: 25 - 50 mm | Diameter: 7 - 9 mm | ||
| Length: 20 - 30 mm | |||
| Material | PLA | PLA | PLA |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Labeling | Sterile, Single Use Only | Sterile, Single Use Only | Sterile, Single Use Only |
Applicant
Bernice Jackson
Date
రా
9
BioRCI Screw 510(k)
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized bird-like symbol, composed of three curved lines that resemble wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith & Nephew, Inc. Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K992396
Trade Name: BioRCI Screw Regulatory Class: II Product Code: HWC Dated: October 19, 1999 Received: October 20, 1999
Dear Mr. Tsakonas:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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
4
Page 2 – Mr. Dcmetrios Tsakonas
If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and additionally 809.10 for im viro diagnostic devices), please contact the Office of Compliance at additionally 809.10 for in Vitto diagnostions on the promotion and advertising of your device, (301) 394-4595. Addinonally, for questions of the p-4639. Also, please note the regulation please contact the Office or Comphance at (301) stuffication" (21 CFR 807.97). Other general entitled, "Misoranding by recreace to premation in a may be obtains of Small
information on your responsibilities under the Act may be obtained from the 1907 of its information on your responsibilities ander the receins, 63-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Yundell Jager
-52 -- James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510 (k) Number (If Known):
510 (k) Number (If Known): K992396
Device Name: BioRCI Screw
Intended Use:
The BioRCI Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Indications:
(Per 21 CFR 801.109)
- The BioRCI Screw is used for fixation of bone-tendon-bone or soft-tissue . grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off)
of General Restorative Devices
(k) Number K-99 2396
Prescription Use X or Over-The-Counter Use