(56 days)
No
The summary describes reusable surgical instruments used with a navigation system, focusing on positional accuracy and compatibility. There is no mention of AI/ML in the device description, intended use, or performance studies. The navigation system itself (Medtronic StealthStation) is mentioned, but the summary does not indicate that the INNOVERSE instruments or their interaction with the system utilize AI/ML.
No.
The device is described as surgical instruments (awls, probes, taps, drivers) used for navigation and placement of spinal implants, not for treating a condition itself.
No.
The document describes the INNOVERSE Navigation Instruments as surgical tools used for precisely locating anatomical structures during spinal surgery to assist in implant placement, not for diagnosing medical conditions.
No
The device description explicitly states that the INNOVERSE Navigation Instruments are "reusable surgical instruments" made from "Stainless Steel per ASTM F899," including awls, probes, taps, and drivers. These are physical hardware components, not software.
Based on the provided information, the INNOVERSE Navigation Instruments are 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.
- INNOVERSE Navigation Instruments Function: The description clearly states that these instruments are surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures and preparing for implant placement. They are used in conjunction with a navigation system that utilizes imaging data (CT, MR, fluoroscopy) and anatomical landmarks.
- No Sample Testing: There is no mention of these instruments being used to test samples from the human body. Their function is entirely focused on guiding surgical procedures based on imaging and anatomical reference.
Therefore, the INNOVERSE Navigation Instruments fall under the category of surgical navigation instruments or computer-assisted surgery (CAS) instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation™, 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.
Product codes
OLO
Device Description
The INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants.
The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.
All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation™ Navigation System hardware and software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Spinal, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, spinal surgery
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)
The INNOVERSE Navigation Instruments have been tested for positional accuracy per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". The results of this non-clinical testing show that performance of the INNOVERSE Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
June 14, 2024
Image /page/0/Picture/1 description: The image shows 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Innosys Co., Ltd. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K241082
Trade/Device Name: INNOVERSE Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 19, 2024 Received: April 19, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Eileen
Digitally signed by
Eileen Cadel -S
Date: 2024.06.14
Cadel -S 11:33:10-04'00'
for
Colin O'Neill, MBE 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
2
Indications for Use
Submission Number (if known)
Device Name
INNOVERSE Navigation Instruments
Indications for Use (Describe)
INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation™, 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K241082 Page 1 of 1
3
510(K) SUMMARY
| Submitter's Name: | Innosys Co., Ltd. |
|---|---|
| Submitter's Address: | 20, Sandan-Ro 76beon-Gil(Rd) |
| Uijeongbu-Si, South Korea 11781 | |
| Submitter's Telephone: | +82 31-860-6839 |
| Contact Person: | Nathan Wright, MS, RAC |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies Logo | |
| Date Summary was Prepared: | April 19, 2024 |
| Trade or Proprietary Name: | INNOVERSE Navigation Instruments |
| Device Classification Name: | Orthopedic Steretaxic Instrument |
| Classification & Regulation #: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Restorative, Repair and Trauma Devices (DHT6C) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants.
The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.
All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation™ Navigation System hardware and software.
INDICATIONS FOR USE
INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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.
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
- Intended Use and Function ●
- Materials of manufacture ●
- Manufacturing and Biocompatibility ●
4
- Sterilization and Packaging
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K223494 | Navigated Reusable Instruments for use with | |||
| StealthStation™ and IPCT™ Powerease™ Systems | Medtronic® | OLO | Primary | |
| K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | NKB | Reference |
Predicate Devices
PERFORMANCE DATA
The INNOVERSE Navigation Instruments have been tested for positional accuracy per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". The results of this non-clinical testing show that performance of the INNOVERSE Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and performance testing data lead to the conclusion that the INNOVERSE Navigation Instruments are substantially equivalent to the predicate devices.