(27 days)
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.
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.
The provided document is a 510(k) premarket notification for the Precision Spine S-COMP Reform® POCT Navigated Instruments. It asserts substantial equivalence to predicate devices based on engineering analysis and geometric comparison, rather than a clinical study with acceptance criteria.
Therefore, many of the requested details, such as specific acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC study details, are not applicable or not available in this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the document:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific performance metrics (e.g., accuracy in mm). The submission relies on "engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
- Reported Device Performance: "The results of the engineering analysis show that the subject is substantially equivalent to the cleared predicates." This implies that the device is expected to perform comparably to the predicate devices, which are already considered safe and effective for their intended use. Specific numerical performance data is not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set of cases (e.g., patient images or surgical data) was used for evaluating software performance. The evaluation was based on engineering analysis and geometric comparison of the instruments themselves.
- Data Provenance: Not applicable, as there was no data set for performance evaluation in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth was not established by experts on a test set of data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and engineering analysis, not reader performance with or without AI assistance. The device is a surgical instrument, not an AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. The device is a physical surgical instrument intended to be used with a navigation system and by a surgeon. It is not an algorithm that performs actions standalone.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of clinical performance data. The "truth" in this submission relies on the established safety and efficacy of the predicate devices and the engineering analysis demonstrating that the new instruments are geometrically similar and function comparably.
8. The Sample Size for the Training Set
- Training Set Size: Not applicable. This is not an AI/ML algorithm that requires a training set. The device is a physical surgical instrument.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
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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.
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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
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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)
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| Submitter's Name: | Precision Spine, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive DrivePearl, Mississippi 39208 |
| Submitter's Telephone: | 201-953-0500 |
| Contact Person: | Nathan Wright MSEmpirical Technologies719-351-0248nwright@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 |
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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.
§ 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).