(29 days)
Not Found
No
The summary describes a physical implant (cervical spacer) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is intended to treat cervical disc degeneration and/or cervical spinal instability by facilitating fusion, which is a method of treating a disease or injury.
No
This device is an implantable spacer intended for the treatment of cervical disc degeneration and/or spinal instability, not for diagnosing these conditions. Its purpose is to facilitate fusion and provide structural support, often used after diagnosis by imaging studies.
No
The device description clearly describes a physical implant (structural column, openings, cavity, teeth) intended for surgical implantation in the cervical spine. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The GPS™ Cervical Spacers are implants designed to be surgically placed in the cervical spine to facilitate bone fusion and treat conditions like disc degeneration and instability. They are a physical device used within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical implant for treating spinal conditions, not a diagnostic test.
- Device Description: The description details the physical structure and function of an implantable device.
The information about imaging studies (radiographs, CT, MRI) is used to diagnose the patient's condition before the device is implanted, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The GPS™ Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRD) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.
Product codes
ODP
Device Description
The basic shape of the GPS™ Cervical Spacers is a structural column having upper and lower implant openings and a central cavity for autograft bone. The devices have a have a "B" shaped cross-section. Surface teeth assist in the seating the implant between the vertebral bodies. Devices are available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
Cervical spine, from C2-T1
Indicated Patient Age Range
skeletally mature patients
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)
No new mechanical testing was performed for the GPS™ Cervical Spacers because the non-sterile condition does not create a mechanical worst case with respect to performance. Performance data remains unchanged for the subject devices as compared to the predicate versions of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GPS™ Spacers (G Surgical LLC - K142456)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 23, 2021
G Surgical LLC % Karen E. Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K210890
Trade/Device Name: GPSTM Cervical Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 24, 2021 Received: March 25, 2021
Dear Dr. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
GPSTM Cervical Spacers
Indications for Use (Describe)
The GPS™ Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRD) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Co |
Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date: | 24 March 2021 |
|---|---|
| Sponsor: | G Surgical LLC |
| 9433 Bee Cave Road | |
| Building 3, Suite 101-A | |
| Austin, Texas 78733 USA | |
| Tel.: 512.494.4749 | |
| Sponsor Contact: | Don Grafton, Managing Director |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | GPS™ Cervical Spacers |
| Common Name: | Interbody fusion device |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral body fusion device, 21 CFR 888.3080, ODP |
| Submission Purpose: | The subject 510(k) expands the product offering by adding a non-sterile |
| implant option. In addition, the Indications for Use statement has been | |
| revised to expand usage from one to multiple contiguous levels and to add | |
| allogeneic bone graft. | |
| Device Description: | The basic shape of the GPS™ Cervical Spacers is a structural column |
| having upper and lower implant openings and a central cavity for autograft | |
| bone. The devices have a have a "B" shaped cross-section. Surface teeth | |
| assist in the seating the implant between the vertebral bodies. Devices are | |
| available in a variety of size and angulation combinations to accommodate | |
| the diversity in patient anatomy. | |
| Indications for Use: | The GPS™ Cervical Spacers are indicated for use at multiple contiguous |
| levels, from C2-T1, in skeletally mature patients who have had six weeks of | |
| non-operative treatment. The device is intended to treat cervical disc | |
| degeneration and/or cervical spinal instability as confirmed by imaging | |
| studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy | |
| and/or pain. The device is to be used with autogenous and/or allogeneic | |
| bone graft comprised of cancellous and/or corticocancellous bone graft to | |
| facilitate fusion and in combination with supplemental fixation cleared for | |
| use in the cervical spine. | |
| Materials: | The GPS™ Spacers are manufactured from polyetheretherketone (PEEK) |
| per ASTM F2026 (VESTAKEEP® i4 R, Evonik Polymers Technologies | |
| GmbH). Integral marker pins are manufactured from tantalum according to | |
| ASTM F560. | |
| Primary Predicate: | GPS™ Spacers (G Surgical LLC - K142456) |
| Performance Data: | No new mechanical testing was performed for the GPS™ Cervical Spacers |
| because the non-sterile condition does not create a mechanical worst case | |
| with respect to performance. Performance data remains unchanged for the | |
| subject devices as compared to the predicate versions of the device. |
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| Technological
Characteristics: | The GPS™ Cervical Spacers possess the same technological
characteristics as the sterile versions of themselves. These include: |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • performance (as described above), |
| | • basic design (hollow structural frame), |
| | • material (PEEK polymer and tantalum) and |
| | • sizes (identical to those previously cleared) |
| | The fundamental scientific technology of the GPS™ Spacers is the same as
previously cleared devices. |
| Conclusion: | The GPS™ Cervical Spacers possess the same intended use and
technological characteristics as the predicate devices. Therefore GPS™
Spacers are substantially equivalent for their intended use. |