(27 days)
No
The summary describes navigated surgical instruments that interact with a separate navigation system (Medtronic StealthStation®). The instruments themselves are passive and do not contain AI/ML. The navigation system, while using imaging data, is not explicitly stated to use AI/ML in this summary.
No.
This device is an instrument used to assist surgeons in precisely locating anatomical structures during spinal surgery; it does not directly treat or diagnose a medical condition.
No
Explanation: The device is described as "re-usable surgical instruments" used during spinal surgery to assist in locating anatomical structures with a navigation system. It does not state that it is used to diagnose a medical condition.
No
The device description explicitly states the device is "non-sterile, re-usable surgical instruments made from stainless steel," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The S-COMP Reform® POCT Navigated Instruments are surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures. They are used in conjunction with a navigation system that utilizes imaging data (CT, MR, fluoroscopy) and digitized landmarks.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. Its function is to provide guidance and positioning during a surgical procedure.
Therefore, the intended use and function of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Precision Spine S-COMP Reform® POCT Navigated Instruments are indicated for use during the preparation and placement of Precision Spine Reform® POCT Polyaxial Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated instruments are reusable and are specifically designed for use with the Medtronic StealthStation® System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the S-COMP Reform® POCT Navigated Instruments with the Medtronic StealthStation® System is limited to use with the Reform® POCT Spinal Fixation System when the correct Infinity™ tool cards are selected.
Product codes
OLO
Device Description
The S-COMP Reform® POCT Navigation Instruments are non-sterile, re-usable surgical instruments made from stainless steel. These instruments are designed to interact with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
The purpose of this submission is to add instruments to the previously cleared Precision Spine Navigation Instrumentation set to offer compatibility with the Reform® POCT System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
The S-COMP Reform® POCT Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance. The results of the engineering analysis show that the subject is substantially equivalent to the cleared predicates.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2023
Precision Spine, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K231229
Trade/Device Name: S-COMP Reform® POCT Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 28, 2023 Received: April 28, 2023
Dear Nathan Wright:
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.
1
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 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 mediation-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.
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
S-COMP Reform® POCT Navigated Instruments
Indications for Use (Describe)
Precision Spine S-COMP Reform® POCT Navigated Instruments are indicated for use during the preparation and placement of Precision Spine Reform® POCT Polyaxial Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated instruments are reusable and are specifically designed for use with the Medtronic StealthStation® System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the S-COMP Reform® POCT Navigated Instruments with the Medtronic StealthStation® System is limited to use with the Reform® POCT Spinal Fixation System when the correct Infinity™ tool cards are selected.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Submitter's Name: | Precision Spine, Inc. |
---|---|
Submitter's Address: | 2050 Executive Drive |
Pearl, Mississippi 39208 | |
Submitter's Telephone: | 201-953-0500 |
Contact Person: | Nathan Wright MS |
Empirical Technologies | |
719-351-0248 | |
nwright@empiricaltech.com | |
Date Summary was Prepared: | April 28, 2023 |
Trade or Proprietary Name: | S-COMP Reform® POCT Navigated Instruments |
Device Classification Name: | Orthopedic Stereotaxic Instruments |
Classification & Regulation #: | Class II per 21 CFR §882.4560 |
Product Code: | OLO |
Classification Panel: | Orthopedic - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The S-COMP Reform® POCT Navigation Instruments are non-sterile, re-usable surgical instruments made from stainless steel. These instruments are designed to interact with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
The purpose of this submission is to add instruments to the previously cleared Precision Spine Navigation Instrumentation set to offer compatibility with the Reform® POCT System.
INDICATIONS FOR USE
Precision Spine S-COMP Reform® POCT Navigated Instruments are indicated for use during the preparation and placement of Precision Spine Reform® POCT Polyaxial Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated instruments are reusable and are specifically designed for use with the Medtronic StealthStation® System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the S-COMP Reform® POCT Navigated Instruments with the Medtronic StealthStation® System is limited to use with the Reform® POCT Spinal Fixation System when the correct Infinity™ tool cards are selected.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Principles of Operation
Predicate Devices
510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
---|---|---|---|
K181111 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | Primary |
K181606 | Precision Spine Navigation Instrumentation | Precision Spine | Additional |
4
Performance Data
The S-COMP Reform® POCT Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance. The results of the engineering analysis show that the subject is substantially equivalent to the cleared predicates.
CONCLUSION
The overall technology characteristics and engineering analysis lead to the conclusion that the S-COMP Reform® POCT Navigation Instruments are substantially equivalent to the predicate device.