(90 days)
a) General orthopedic uses.
b) Trochanteric reattachment.
c) Fixation of long bone fractures-elbow, shoulder, ankle, patella.
d) Trauma fixation of shoulder, ankle and patella .
e) General spinal uses.
f) Spinal wiring.
This implant consists of a 0.058" diameter cable, 23" in length, 20" length cable and 3" length lead and a cylindrical crimp with a transverse "through hole". The crimp, cable and lead cable are supplied as a single assembled unit. All three are preassembled in the manufacturing process. The cable is manufactured according to the material specifications for ASTM F136-96 in a 7 x 7 x 0.00064 wire construct. The crimp is also manufactured from ASTM F136-96.
A cable passer may be used to pass the free end of the cable around the bone. The free end is then passed through the transverse hole of the crimp in such manner as to have the free end emerge from the center of the crimp. A cable tensioner may be used to achieve a desired cable tension a which time the surgeon uses a crimper/cutter to crimp near the middle of the "through hole" and cuts the free end from the crimp.
The provided text is a 510(k) summary for a medical device called the "Whiteside Biomechanics Low-Profile Titanium Cable System." This document is part of the FDA regulatory process to demonstrate that a new medical device is substantially equivalent to a previously cleared device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've described for a diagnostic or AI-powered device.
The 510(k) process for a physical implantable device like a surgical cable ("Bone Fixation Cerclage") typically focuses on demonstrating material equivalence, manufacturing processes, and functional equivalence (e.g., tensile strength, fatigue resistance) to a predicate device, rather than diagnostic performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
Therefore, I cannot provide the requested information from the given text because:
- Acceptance Criteria and Device Performance Table: The document does not define specific performance acceptance criteria for the device (e.g., tensile strength thresholds, fatigue cycles) nor does it report the results of a study against such criteria. The focus is on demonstrating "substantial equivalence" to a predicate device based on similar design, material, and intended use.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic studies): These categories are relevant for studies evaluating the diagnostic performance of software or imaging devices. They are not applicable to the type of regulatory submission presented for a physical surgical cable. The "study" referenced in K993903 is an assessment of the device's characteristics against its predicate, not a clinical trial or performance study as you might expect for a diagnostic AI.
- Training Set Sample Size and Ground Truth: This is also not relevant as there is no AI or diagnostic algorithm being described.
Summary based on the provided document:
The regulatory document (K993903) for the Whiteside Biomechanics Low-Profile Titanium Cable System asserts substantial equivalence to an existing predicate device (Whiteside Biomechanics Low-Profile Cable System K951844).
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness.
- Study That Proves the Device Meets Acceptance Criteria: The "study" is the comparison made as part of the 510(k) submission. The document states:
- "There are no different technological characteristics between the Whiteside Biomechanics Low-Profile Cable System and the Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System."
- The cable is manufactured according to ASTM F136-96 material specifications.
- The crimp is also manufactured from ASTM F136-96.
This indicates that the device meets the "acceptance criteria" by being materially and technologically identical (or very similar, without introducing new risks) to a device already cleared by the FDA. There is no mention of a human-in-the-loop study, a standalone algorithm, or diagnostic performance metrics because this is a physical medical implant, not a diagnostic AI system.
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FEB 1 4 2000
K 993903/A'
PAGE 1 OF 2
Section 4: 510(k) Summary
| Company Name/Address: | Whiteside Biomechanics, Inc.12634 Olive Blvd.St. Louis, MO 63141P: 314-996-8540F: 314-996-8543 |
|---|---|
| Establishment Registration #: | 1932213 |
| Correspondent: | Debra Meyer |
| Device Name: | Whiteside Biomechanics Low-ProfileTitanium Cable System |
| Proprietary Name: | Whiteside Biomechanics, Inc. Low-ProfileTitanium Cable System |
| Common Name: | Surgical Cable |
| Classification Name: | Bone Fixation Cerclage |
| Classification Panel: | General & Plastic Surgery |
| Substantial Equivalence To: | Whiteside Biomechanics Low-Profile CableSystem (K951844) |
Device Description:
This implant consists of a 0.058" diameter cable, 23" in length, 20" length cable and 3" length lead and a cylindrical crimp with a transverse "through hole". The crimp, cable and lead cable are supplied as a single assembled unit. All three are preassembled in the manufacturing process. The cable is manufactured according to the material specifications for ASTM F136-96 in a 7 x 7 x 0.00064 wire construct. The crimp is also manufactured from ASTM F136-96.
A cable passer may be used to pass the free end of the cable around the bone. The free end is then passed through the transverse hole of the crimp in such manner as to have the free end emerge from the center of the crimp. A cable tensioner may be used to achieve a desired cable tension a which time the surgeon uses a crimper/cutter to crimp near the middle of the "through hole" and cuts the free end from the crimp.
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Device Intended Use:
a) General orthopedic uses.
- b) Trochanteric reattachment.
- c) Fixation of long bone fractures-elbow, shoulder, ankle, patella.
- d) Trauma fixation of shoulder, ankle and patella .
- e) General spinal uses.
- f) Spinal wiring.
Technological Comparison:
The Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System is substantially equivalent to the predicate device. There are no different technological characteristics between the Whiteside Biomechanics Low-Profile Cable System and the Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2000
Ms. Debra R. Meyer Whiteside Biomechanics, Inc. 12634 Olive Boulevard St. Louis, Missouri 63141
Re: K993903 Trade Name: Whiteside Biomechanics Low-Profile Titanium Cable System Regulatory Class: II Product Code: JDQ Dated: November 12, 1999 Received: November 16, 1999
Dear Ms. Meyer:
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 control provisions of the Act. The general control 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 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. Debra R. Meyer
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 yours,
Nil RP Ogden
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Section 10:
Device Intended Use:
- a) General orthopedic uses.
- b) Trochanteric reattachment.
- c) Fixation of long bone fractures-elbow, shoulder, ankle, patella.
- d) Trauma fixation of shoulder, ankle and patella .
- e) General spinal uses.
- f) Spinal wiring.
NRO for IZD
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993903
X Prescription Use . (Per 21 CFR 801.109)
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.