Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis of the cervical vertebrae
Spinal stenosis of the cervical vertebrae
Atlanto/axial fracture with instability
Cervical-occipital dislocation
Revision of previous cervical spine surgery
Tumors

Device Description

The Ransford Cervical Fixation System consists of various loops (in stainless steel and titanium, with different angles and lengths), stainless steel and titanium cross links, and surgical instruments. These implants are designed for use with annealed stainless steel wire 0.9mm diameter (20swg) or multi-filament braided titanium alloy (6A),4V) cable, 0.045 inch (1.1mm) diameter, 19 inches long with a 3 inch, soft, pure titanium mono-filament lead wire. The system is based on sublaminar wires and contoured rods placed posteriorly.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the RANSFORD CERVICAL FIXATION SYSTEM™, which is a medical device. The primary method for proving the device meets acceptance criteria in a 510(k) submission is to demonstrate substantial equivalence to an already legally marketed predicate device. This is achieved through comparison of design, materials, intended use, and performance data.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the characteristics of the predicate device, the Hartshill Spinal Fixation System (K853033). The RANSFORD CERVICAL FIXATION SYSTEM™ must perform "substantially the same" as the predicate device.

Feature / Acceptance Criteria	Reported Device Performance (RANSFORD CERVICAL FIXATION SYSTEM™)
Intended Use: Surgical stabilization of the cervical spine and cervical occipital junction.	Surgical stabilization alone and surgical stabilization and fusion of the cervical spine and cervical occipital junction. (Same as predicate)
Indications for Use:	Degenerative disk disease, spondylolisthesis, spinal stenosis, atlanto/axial fracture with instability, cervical-occipital dislocation, revision of previous cervical spine surgery, tumors. (Same cervical indications for use as predicate)
Materials: Stainless Steel	Titanium and stainless steel (Evolutionary improvement: also uses Titanium, which is noted to offer enhanced clinical performance in axial extension and axial compression tests, and titanium cables show increased stiffness and force at gross failure compared to stainless steel wires).
Surgical Approach: Posterior	Posterior (Same as predicate)
Method of Attachment: Wires to occiput and posterior arches.	Wires to occiput and posterior arches (Same as predicate)
Axial Torsion Performance: Similar stiffness, torque at gross failure, and angular rotation at gross failure as the predicate.	No statistically significant difference in stiffness, torque at gross failure, and angular rotation at gross failure for titanium Ransford Loop vs. stainless steel Hartshill Cervical Rectangle. Mean stiffness and torque at gross failure are higher for titanium Ransford, and mean angle at gross failure is lower.
Axial Extension Performance: Similar stiffness, force at gross failure, and extension at gross failure as the predicate.	Statistically significant increase in stiffness, increase in the force at gross failure, and decrease in the extension at gross failure for titanium Ransford Loop vs. stainless steel Hartshill Cervical Rectangle. This is believed to enhance clinical performance.
Axial Compression Performance: Similar stiffness, force at gross failure, and extension at gross failure as the predicate.	Statistically significant increase in stiffness, increase in the force at gross failure, and increase in the extension at gross failure for titanium Ransford Loop vs. stainless steel Hartshill Cervical Rectangle. This is believed to enhance clinical performance.
Cable/Wire Tensile Strength: Similar performance to predicate.	Statistically significant increase in stiffness and force at gross failure of titanium cables compared to stainless steel wires. Wires have longer extension to gross failure than cables.
Sterilization: Able to be sterilized effectively.	Recommended sterilization method is gravity steam sterilization for 30 minutes at 121°C (250° F) with a Sterility Assurance Level (SAL) of 10⁻⁶. Validation conducted by qualified commercial laboratories using the overkill method based on HIMA & AORN protocols. (This demonstrates effective sterilization, similar to what would be expected for a predicate device).

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in the static mechanical tests. The document does not explicitly state the exact sample sizes for each mechanical test (Axial Torsion, Axial Extension, Axial Compression, Cable/Wire Tensile Test). It refers to "tests conducted" without providing N numbers.

The data provenance is laboratory-based mechanical testing, comparing the RANSFORD CERVICAL FIXATION SYSTEM™ components (titanium Ransford Loop and titanium cables) directly to components of the Hartshill Spinal Fixation System (stainless steel Hartshill Cervical Rectangle and stainless steel wires). There is no mention of human subject data, animal data, or clinical data in this safety and effectiveness summary. The tests were "conducted by qualified commercial laboratories." The country of origin for the testing is not specified, but the manufacturer is based in England.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable in this context. Ground truth is typically established in studies involving diagnostic devices or algorithms that interpret data (e.g., medical images). For a mechanical fixation system like this, the "ground truth" is defined by the physical properties and performance characteristics measured in static mechanical tests. The "experts" are the "qualified commercial laboratories" that conducted the tests, and their "qualifications" implicitly relate to their ability to perform such mechanical testing according to established protocols.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts in diagnostic studies. For mechanical tests, the results are quantitative measurements, and statistical comparisons determine whether differences are significant. There is no human interpretation or adjudication in the sense described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers (e.g., radiologists, pathologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. The RANSFORD CERVICAL FIXATION SYSTEM™ is a spinal implant, not a diagnostic device, so such a study would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the RANSFORD CERVICAL FIXATION SYSTEM™ is a physical surgical implant, not an algorithm or AI system. Its performance is assessed through mechanical testing, not through standalone algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is based on direct physical measurement of mechanical properties (stiffness, torque, force, angular rotation, extension) under controlled laboratory conditions, as compared to the established performance of the predicate device. It is a performance benchmark against a known, legally marketed device.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant, not an AI system, and therefore has no training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as in point 8.

Summary

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AUG - 7 1997

Section 510(k) Premarket NotificationSURGICRAFT, LIMITED	Summary of Safety and Effectiveness Information forthe RANSFORD CERVICAL FIXATION SYSTEM™
--------------------------------------------------------------	-----------------------------------------------------------------------------------------------

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

TRADE NAME:	RANSFORD CERVICAL FIXATION SYSTEMTM
Common Name:	Cervical spinal implant
Classification Name:	Appliance, Fixation, Spinal Interlaminar

2. Establishment Name & Registration Number:

Name: SURGICRAFT, LTD.

Number: 8020712

Classification: 3.

§ 888.3050 Spinal interlaminal fixation orthosis. (a) Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. (b) Classification. Class II.

87KWP Product Code:

Device Class: Class II

Classification Panel: Orthopaedics and rehabilitation devices panel

5. Contact Person:

Mr. Simon Fitzer SURGICRAFT, LIMITED REDDITCH, WORCESTERSHIRE B97 6HF, ENGLAND 01527 66331 VOICE 01527 65295 FAX

ર. Special Controls:

Special controls have not been established for this device.

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7. Device Description:

ﻤﺴﺴﺴﺴﺴﺴﺴ

Cleared Intended Use:

Surgical stabilization to assist bony fusion of the cervical spine and cervical junction.

Cleared Indications For Use:

1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
1. spondylolisthesis of the cervical vertebrae
1. Spinal stenosis of the cervical vertebrae
1. Atlanto/axial fracture with instability
1. Cervical-occipital dislocation
1. Revision of previous cervical spine surgery
1. Tumors

The Ransford Cervical Fixation System consists of the following items:

HRL 4010 - Randsford Loop 100° OC Angle, 10mm Stainless Steel HRL 4015 - Randsford Loop 100° OC Angle, 15mm Stainless Steel HRL 4020 - Randsford Loop 100° OC Angle, 20mm Stainless Steel HRL 4045 - Randsford Loop 100° OC Angle, X-long, 10mm SS (w/3 cross links) HRL 3201 - Randsford Loop, pediatric size - (multi-waisted design) HRLR 4009 - Randsford Loop 90% 100° OC Angle, 9mm Stainless Steel HRLR 4013 - Randsford Loop 90% 100° OC Angle. 13mm Stainless Steel HRLR 4018 - Randsford Loop 90% 100° OC Angle, 18mm Stainless Steel HRLC 4150 - Stainless Steel Cross Link

HTL 4410 - Randsford Loop 100° OC Angle, 10mm Ti HTL 4415 - Randsford Loop 100° OC Angle, 15mm Ti HTL 4420 - Randsford Loop 100° OC Angle, 20mm Ti HTL 4445 - Randsford Loop 100° OC Angle, X-long, 10mm Ti (w/3 cross links) HTLR 4409 - Randsford Loop 90% 100° OC Angle, 9mm Ti HTLR 4413 - Randsford Loop 90% 100° OC Angle. 13mm Ti HTLR 4418 - Randsford Loop 90% 100° OC Angle, 18mm Ti

HTL 4610 - Randsford Loop 115° OC Angle, 10mm Ti HTL 4615 - Randsford Loop 115° OC Angle, 15mm Ti HTL 4620 - Randsford Loop 115° OC Angle, 20mm Ti HTL 4645 - Randsford Loop 115° OC Angle, X-long, 10mm Ti (w/3 cross links)

HTLR 4609 - Randsford Loop 90% 115° OC Angle, 9mm Ti HTLR 4613 - Randsford Loop 90% 115° OC Angle, 13mm Ti HTLR 4618 - Randsford Loop 90% 115° OC Angle, 18mm Ti

HTRLC 4450 - Titanium Cross Link

Surgical instruments designed to help implant the device are also available.

These implants are designed for use with annealed stainless steel wire 0.9mm diameter (20swg). This wire is the same wire cleared for use with the Hartshill Rectangle Spinal devices and is supplied by Surgicraft, Ltd.

Surgifinal.doc

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Titanium alloy implants are designed for use with multi-filament braided titanium alloy (6A),4V) cable, 0.045 inch (1.1mm) diameter, 19 inches long with a 3 inch, soft, pure titanium mono-filament lead wire. This wire is the same type of wire cleared for use with Sofamor/Danek spinal devices.

8. Substantially Equivalent Device(s):

The RANSFORD CERVICAL FIXATION SYSTEM" is substantially equivalent to the following device:

1. Hartshill Spinal Fixation System - K853033

9. Comparison to Predicate Device(s):

Surgicraft, Ltd. currently marketed device for the same indications as the Ransford Loop. That other device is listed above. A 510(k) Premarket Notification for the Hartshill device established the substantial equivalence of that system in 1985 to earlier preamendment spinal fixation systems. The Ransford CERVICAL FIXATION SYSTEM" is substantially equivalent to the earlier Hartshill Spinal Fixation System.

Both the Hartshill Spinal Fixation System and the RANSFORD CERVICAL FIXATION SYSTEM" are posterior attachment surgical approach systems. Both systems may be used to treat the same medical or surgical conditions of the cervical spine. Both systems have essentially the same cautions and contraindications for use. Both are basic spinal rod, crosslink and sublaminar wiring systems. Both systems may be attached to the occiput via bore holes and wires.

Evolutionary development of long established engineering, design and medical treatment principles combines to offer predictable clinical performance for the requested cervical indications. The system is based on sublaminar wires and contoured rods placed posteriorly. This concept has been in common use for more than 35 years. Most orthopaedic and neurosurgeons physicians are already extensively experienced in these techniques and may be expected to adapt readily to the RANSFORD CERVICAL FIXATION SYSTEM." Like the equivalent Hartshill system, the RANSFORD CERVICAL FIXATION SYSTEM" utilizes similar implant materials meeting various BS, ISO and ASTM standards.

Comparison testing and existing clinical performance demonstrates that the RANSFORD CERVICAL FIXATION SYSTEM" performs substantially the same as the earlier Hartshill Spinal Fixation System (K853033). However, pre-contouring of the Ransford implants and the addition of advanced materials offers evolutionary improvements over the Hartshill and other older systems.

10. Packaging:

All implants and instruments are supplied packaged in industry standard medical grade packaging suitable for surgical implants and instruments. Shippers and boxes are of suitable design and materials to ensure protection and identification during shipping and storage.

11. Sterilization/Re-sterilization:

All implants and instruments are supplied Non-sterile implants are packaged in "clean only" condition. Implants are processed to remove manufacturing residue and debris only. All implants and instruments must be removed from their shipping and packing materials then washed and rinsed thoroughly before first use. Sterilization processing is required before the devices may be used.

The recommended sterilization method, time and temperature for the implants is gravity steam sterilization for 30 minutes at 121°C (250° F). The Sterility Assurance Level (SAL) of the recommended sterilization cycle is 10° (SAL 10°). Validation of the recommended cycle has been

Surgifinal.doc

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conducted by qualified commercial laboratories. The validation method used is known as the overkill method.

The recommended sterilization method is based on Health Industry Manufacturers Association (HIMA) & Association of Operating Room Nurses (AORN) protocols. Only the recommended sterilization cvcle was validated.

12. Conclusion:

Static tests were conducted contrasting the RANSFORD CERVICAL FIXATION SYSTEM" with the Hartshill Spinal Fixation System.

Axial Torsion. From the axial torsion tests conducted it was concluded that there is no statistically significant difference in stiffness, torque at gross failure and angular rotation at gross failure of the titanium Ransford Loop compared to the stainless steel Hartshill Cervical Rectangle. The mean stiffness and torque at gross failure are both higher for the titanium Ransford Loop than the stainless steel Hartshill Rectangle and the mean angle at gross failure is lower in the titanium Ransford Loop than the stainless steel Hartshill Cervical Rectangle.

Axial Extension. From the axial extension tests conducted it was concluded that there is a statistically significant increase in stiffness, increase in the force at gross failure and decrease in the extension at gross failure of the titanium Ransford Loop compared to the stainless steel Hartshill Cervical Rectangle. This is believed to enhance the clinical performance of the Ransford Loop compared to the contoured Hartshill Cervical Rectangle.

Axial compression. From the axial compression tests conducted it was concluded that there is a statistically significant increase in stiffness, increase in the force at gross failure and increase in the extension at gross failure of the titanium Ransford Loop compared to the stainless steel Hartshill Cervical Rectangle. This is believed to enhance the clinical performance of the Ransford Loop compared to the contoured Hartshill Cervical Rectangle.

Cable/Wire Tensile Test. From the tensile tests conducted it was concluded that there is a statistically significant increase in stiffness and force at gross failure of the titanium cables compared to the stainless steel wires. The tests also demonstrate that the wires have a longer extension to gross failure than the cables.

Based on a comparison of the device materials, intended uses, surgical technique, implant design, and comparison testing, the RANSFORD CERVICAL FIXATION SYSTEM" is substantially equivalent to the referenced legally marketed Hartshill Spinal Fixation System. The feature comparison chart below graphically illustrates such equivalence.

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13. Comparison Table:

)

FEATURE	RANSFORD CERVICAL FIXATION SYSTEMTM	Hartshill Spinal Fixation SystemTM	SE?
Intended Use:	Surgical stabilization alone and surgicalstabilization and fusion of the cervical spine andcervical occipital junction.	Same cervical intended use.	Yes
Indications ForUse:	Degenerative disk disease of the cervicalvertebrae (neck pain of discogenic origin withdegeneration of the disc as confirmed bypatient history and radiographic studies)spondylolisthesis of the cervical vertebraeSpinal stenosis of the cervical vertebraeAtlanto/axial fracture with instabilityCervical-occipital dislocationRevision of previous cervical spine surgeryTumors	Same cervical indications for use.	Yes
Materials:	Titanium and stainless steel	Stainless steel	Yes
SurgicalApproach:	Posterior	Posterior	Yes
Method ofAttachment:	Wires to occiput and posterior arches	Wires to occiput and posterior arches	Yes
K-Number	K965221	K853033	Yes
Manufacturer:	Surgicraft, Ltd.	Surgicraft, Ltd.	Yes

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol of three human profiles facing to the right, with three curved lines above them. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David W. Schlerf Buckman Company Inc. 1000 Burnett Avenue, Suite 450 Concord, California 94520

AUG - 7 1997

Re: K965221 Ransford Loop Cervical Fixation System Regulatory Class: II Product Code: KWP Dated: July 27, 1997 Received: July 29, 1997

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 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 your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

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Page 2 - Mr. David W. Schlerf

1. You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, "WARNING: "This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";
1. All labeling for this device system, including the package label, must state that there are labelinq limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
1. Pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

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. ਬੋ 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 requlation (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.

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Paqe 3 - Mr. David W. Schlerf

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components: " " " " " Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 requlation 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,
to coee

Celia 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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510(k) Number (if known):

RANSFORD CERVICAL FIXATION SYSTEM Device Name:

Intended Use:- ...............................................................................................................................................................

Surgical stabilization to assist bony fusion of the cervical spine and cervical occipital junction.

Indications For Use:

1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
1. spondylolisthesis of the cervical vertebrae
1. Spinal stenosis of the cervical vertebrae
1. Atlanto/axial fracture with instability --
1. Cervical-occipital dislocation
1. Revision of previous cervical spine surgery

ﺎ ﮐﮧ

1. Tumors

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Acool

aral Re

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Surgi2.doc

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.