(811 days)
The Cross Medical Bone Plate System is intended for non-spinal applications only in the treatment of internal fixation of pelvic fractures.
3.5 mm x 8 mm Bone Screw through 3.5 mm x 30 mm Bone Screw in 2 mm increments
4.0 mm x 8 mm Bone Screw through 4.0 mm x 30 mm Bone Screw in 2 mm increments
C-Plates Assorted Sizes
Device specific instrumentation is necessary for the insertion and anchoring of the CM Bone Plate System. System instrumentation includes: Plate Holder, Plate Cutter, Plate Bender, Plate Shaper, Plate Template, Drill Guide, Drill Bits, Driver Handle, Screw Taps, Screwdriver, Screw Holder, Sterilizer Case.
The implants of the new system are made from titanium alloy (6A1, 4V, ELI) and CP titanium or from 22-23-5 Stainless Steel.
The titanium bone plates are made from commercially pure titanium meeting ASTM F67-89. This material is also known as Commercially Pure Titanium (CP Ti, Grade 2). The stainless steel bone plates are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The titanium bone screws are made from the industry standard alloy Ti 6A1-4V ELI, ASTM F-136-92. The stainless steel bone screws are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The surface of both the titanium screws and titanium plates are anodized and/or matte finished. The surface of both the stainless steel screws and stainless steel plates are matte finished.
The CP titanium plates are offered for their ease of contouring and their mechanical performance.
This document is primarily a premarket notification (510(k)) for the Cross Medical Bone Plate System, seeking to establish substantial equivalence to previously marketed devices. It is not a study that proves a device meets specific acceptance criteria in the way a clinical trial or performance study for a novel device would. Instead, the "acceptance criteria" here are the regulatory requirements for showing substantial equivalence.
Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and comparison with AI performance are not applicable to this type of regulatory submission. The document focuses on demonstrating that the device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use.
Here's an attempt to answer the questions based on the provided text, with clarifications on applicability where necessary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k)) | Reported Device Performance (Summary of how it meets criteria) |
|---|---|
| Material Composition Equivalence | Titanium plates: Commercially Pure Titanium (CP Ti, Grade 2), ASTM F67-89. Stainless steel plates: ASTM F-1314 (22-23-5 Stainless Steel). Titanium screws: Ti 6A1-4V ELI, ASTM F-136-92. Stainless steel screws: ASTM F-1314 (22-23-5 Stainless Steel). These materials are stated as "industry standard alloy" and conform to recognized ASTM standards, implying equivalence to predicate devices. |
| Device Design/Specifications Equivalence | Bone Screws: 3.5 mm x 8 mm to 3.5 mm x 30 mm (2 mm increments), and 4.0 mm x 8 mm to 4.0 mm x 30 mm (2 mm increments). C-Plates: Assorted Sizes. Design descriptions are provided, and substantial equivalence is claimed against Ace and Synthes brand bone plates and screws, suggesting comparable designs. |
| Intended Use Equivalence | Non-spinal applications only, specifically for internal fixation of pelvic fractures. This matches the intended use of legally marketed predicate devices for which substantial equivalence is being claimed. |
| Sterilization Protocol Validity | Recommended sterilization cycle: Steam, Gravity, 250° F (121° C) for 30 minutes, "laboratory validated." This aligns with HIMA/AORN protocols and provides a validated method. The device is supplied non-sterile. |
| Instrumentation Compatibility/Safety | System includes Plate Holder, Cutter, Bender, Shaper, Template, Drill Guide, Drill Bits, Driver Handle, Screw Taps, Screwdriver, Screw Holder, Sterilizer Case. Instruments made from stainless steel (ASTM F-899-84 and/or A276-91 standards). These are described as "standard manual orthopaedic surgical instruments ordinarily exempt from 510(k)" and are included for completeness, implying they are well-established and safe. |
| Overall Safety and Effectiveness (Substantial Equivalence) | "Based on the basic design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis, Cross Medical Products, Inc. believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed bone plate and screw systems." The FDA's letter (K961320) confirmed this finding of substantial equivalence based on the submitted information. |
| Performance Standards Adherence (where applicable) | "Food and Drug Administration developed performance standards applicable to the Cross Medical Bone Plate System do not exist." Voluntary standards (vendor/materials certifications, in-house SOP’s, ASTM, ISO) are utilized as appropriate. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" in the sense of patient data. The basis for substantial equivalence relies on material properties, design comparisons, and mechanical testing (mentioned but not detailed). The "data provenance" would refer to the standards and engineering analyses performed.
- The document states: "mechanical testing" was included in the reasoning for substantial equivalence. However, no specific details like sample size, methodology, or results of these tests are provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. As this is not a clinical study involving diagnosis or interpretation, there is no "ground truth" established by experts in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information and comparison to predicate devices. The expertise involved would be in engineering, materials science, and orthopedics for the design and manufacturing, and regulatory affairs for the submission.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or expert adjudication in the context of clinical data interpretation is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a passive implant (bone plate and screw system) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical, surgical implant and does not involve an algorithm.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness of the identified predicate devices (Ace Brand Bone Plates and Screws, Synthes Brand Bone Plates and Screws). The manufacturer demonstrates that their device is sufficiently similar to these legally marketed devices that it raises no new questions of safety or effectiveness.
- The document also implies reliance on engineering standards (ASTM F67-89, ASTM F-1314, ASTM F-136-92, ASTM F-899-84, A276-91) for material composition and HIMA/AORN protocols for sterilization, which serve as benchmarks for performance and safety.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an algorithm or AI-driven device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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66/19/98 FRI 15:34 FAX 团 012
JUN 25 1998
Summary of Safety and Effectiveness Information (for release on request only)
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact:
| Company: | Cross Medical Products, Inc. |
|---|---|
| 5160 Blazer Memorial Parkway | |
| Suite A | |
| Dublin, Ohio 43017-1339 | |
| (614)718-0530 FAX (614)718-0540 |
Medical Device Establishment Registration Number: 1526354
- Regulatory Affairs Department Contact: Cross Medical Products, Inc. 5160 Blazer Memorial Parkway Suite A Dublin, Ohio 43017-1339 (614)718-0530 FAX (614)718-0540
Device Name:
| Trade Name: | Cross Medical Bone Plate System |
|---|---|
| Common Name: | Bone Screws and Bone Plates |
| ClassificationName(s): | Screw, Fixation, BonePlate, Fixation, Bone |
| Registration Number: | 1526354 |
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Classification:
"S 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."
" ह 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."
Performance Standards:
Food and Drug Administration developed performance standards applicable to the Cross Medical Bone Plate System do not exist. Until such time as Performance Standards are developed by FDA and published in the Federal Register, Cross Medical Products, Inc. intends to produce this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably Voluntary performance standards, such as vendor and materials present. certifications, in-house SOP's and ASTM Standards and/or ISO standards are utilized as appropriate.
Substantially Equivalent Device(s):
-
- Ace Brand Bone Plates and Screws
-
- Synthes Brand Bone Plates and Screws
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Device Description:
- 3.5 mm x 8 mm Bone Screw through 3.5 mm x 30 mm Bone Screw in 2 mm increments
- 4.0 mm x 8 mm Bone Screw through 4.0 mm x 30 mm Bone Screw in 2 mm increments
C-Plates Assorted Sizes
Instrumentation:
Device specific instrumentation is necessary for the insertion and anchoring of the CM Bone Plate System. System instrumentation includes:
| Plate Holder | Drill Bits |
|---|---|
| Plate Cutter | Driver Handle |
| Plate Bender | Screw Taps |
| Plate Shaper | Screwdriver |
| Plate Template | Screw Holder |
| Drill Guide | Sterilizer Case |
The CM Bone Plate System instruments are made from stainless steel meeting ASTM F-899-84 and/or A276-91 standards. The instruments are simply standard manual orthopaedic surgical instruments ordinarily exempt from 510(k) They are offered for FDA review as accessories to this device Notification. system for the sake of completeness and are a part of this submission.
Intended Use:
The Cross Medical Bone Plate System is intended for non-spinal applications only in the treatment of internal fixation of pelvic fractures.
Warning:
This device is not approved for screw attachment for fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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General.
The implants of the new system are made from titanium alloy (6A1, 4V, ELI) and CP titanium or from 22-23-5 Stainless Steel.
The titanium bone plates are made from commercially pure titanium meeting ASTM F67-89. This material is also known as Commercially Pure Titanium (CP Ti, Grade 2). The stainless steel bone plates are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The titanium bone screws are made from the industry standard alloy Ti 6A1-4V ELI, ASTM F-136-92. The stainless steel bone screws are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The surface of both the titanium screws and titanium plates are anodized and/or matte finished. The surface of both the stainless steel screws and stainless steel plates are matte finished.
The CP titanium plates are offered for their ease of contouring and their mechanical performance.
Contraindications and Cautions.
The existence of the following conditions may complicate or contraindicate treatment using internal fixation: bony abnormalities preventing safe screw fixation, metal sensitivities, morbid obesity, severe osteopenia and localized infections at the site of fixation or other disseminated infections (septicemia).
In general, the CM Bone Plate System should only be implanted by surgeons fully experienced in the use of implants and the required specialized orthopaedic surgery techniques.
Packaging:
All packaging will be of a sufficient design and material quality to provide protection from physical damage during transportation and storage. Typical packaging used for such applications are medical grade peel packs, pouches, boxes or tubes.
Sterilization/Resterilization:
All instruments and implants are supplied Non-Sterile. Non-Sterile instruments and implants are packaged in "clear only" condition. The labeling of the implants & instruments clearly indicates their sterility status. The package insert found in Appendix I (labeling) contains a sterilization/resterilization guideline.
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All packaging materials must be removed prior to sterilization. High temperature r in passage sterilization should be used, with the following cycle having been laboratory validated:
| Method: | Steam |
|---|---|
| Cycle: | Gravity |
| Temperature: | 250° F (121° C) |
| Exposure Time: | 30 minutes |
Note: It is recommended to dry and/or cool the parts to prevent condensation after the steam cycle. Only sterile products should be used in the operative field.
The recommended sterilization cycle is based on HIMA/AORN protocols. Other sterilization methods and cycles may also be suitable. However, individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques.
Substantial Equivalence:
The Cross Medical™ Bone Plate System is substantially equivalent to the Ace and Synthes brand bone plates and screws.
Conclusion:
Based on the basic design concept, the use of established well known materials, feature comparisons, mechanical testing,, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis, Cross Medical Products, Inc. believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed bone plate and screw systems.
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Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a caduceus-like symbol with three figures representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8661 g 2 Minh
Mr. Mark E. Apgar Project Engineer Cross Medical Products, Inc. 5160-A Blazer Memorial Parkway Dublin, Ohio 43017-1339
K961320 Re: Cross Medical Bone Plate System Trade Name: Regulatory Class: II Product Codes: HRS and HWC Dated: April 7, 1998 April 9, 1998 Received:
Dear Mr. Apgar:
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. ਉ 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 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 requlations.
{6}------------------------------------------------
Page 2 - Mr. Mark E. Apgar
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 requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Gordon Van Houten, Ph.D.
Celra M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K961320
Device Name: Cross Medical Bone Plate System
Indications For Use:
The Cross Medical Bone Plate System is intended for non-spinal applications only in the treatment of internal fixation of pelvic fractures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
bóllos
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.