(59 days)
No
The summary describes reusable surgical instruments used with a navigation system, focusing on mechanical properties and positional accuracy testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself (Medtronic StealthStation) is mentioned, but the focus of this 510(k) is on the instruments, not the underlying navigation technology which may or may not incorporate AI/ML.
No.
The device is a set of reusable surgical instruments (taps, probes, and drivers) used for navigation during pedicle screw placement in spinal surgery, not a therapeutic device designed to treat a disease or condition directly.
No
Explanation: The device is described as surgical instruments (taps, probes, drivers) used with a navigation system to assist surgeons in precisely locating anatomical structures and helping with the placement of pedicle screws. Its function is to guide surgical procedures, not to diagnose medical conditions or identify diseases.
No
The device description explicitly states that the device includes reusable surgical instruments made of stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The RESPONSE™ Navigation Instruments are surgical instruments used during surgery to assist the surgeon in precisely locating anatomical structures and preparing for implant placement. They are used directly on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use clearly states they are for use "during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures." This is a surgical navigation and instrumentation function, not an in vitro diagnostic function.
Therefore, the RESPONSE™ Navigation Instruments fall under the category of surgical instruments and navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® Stealthstation® S8 System (V1.2.0), 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 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 OrthoPediatrics RESPONSE™ Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.
The RESPONSE™ Navigation Instruments include taps, probes, and drivers. The RESPONSE™ Navigation Instruments are to be used with the RESPONSE™ Spine System.
All instruments are made of stainless steel per ASTM F899. Taps range in size from O3mm to O8mm. The RESPONSE™ 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
Vertebra (Spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons in open procedures
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)
A detailed dimensional analysis and comparison has been conducted for subject and predicate device to support the substantial equivalence.
Additionally, the RESPONSE™ Navigation Instruments have been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems".
- . Single point measurement accuracy per ASTM F2554-18
- Instrument axis rotation measurement accuracy per ASTM F2554-18
- . Instrument angular position perpendicular to the system camera measurement accuracy per ASTM F2554-18
- . Instrument angular position parallel to the system camera measurement accuracy per ASTM F2554-18
- . Distance between points measurement accuracy per ASTM F2554-18
The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the RESPONSE™ 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)
K193100/K181390, K160466/K150600
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 19, 2021
OrthoPediatrics, Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K203573
Trade/Device Name: RESPONSE™ Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO
Dear Yan Li:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 4, 2021. Specifically, FDA is updating this SE Letter to correct a typo in the trade name in the indications for use statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices by phone (1-301-796-2356) or by email (Shumaya.Ali@fda.hhs.gov).
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 Quality Center for Devices and Radiological Health
1
February 4, 2021
Image /page/1/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
OrthoPediatrics, Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K203573
Trade/Device Name: RESPONSE™ Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 4, 2020 Received: December 7, 2020
Dear Yan Li:
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
2
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,
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K203573
Device Name RESPONSE™ Navigation Instruments
Indications for Use (Describe)
RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® S8 System (V1.2.0), 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 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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Image /page/4/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child's face with a smile, and the word "OrthoPediatrics" written in a playful font. The word "Ortho" is written in blue, and the word "Pediatrics" is written in red. The logo is likely used to represent a medical practice that specializes in orthopedic care for children.
510(K) SUMMARY
| Submitter's Name: | OrthoPediatrics, Corp. |
|---|---|
| Submitter's Address: | 2850 Frontier Drive, Warsaw, IN 46582 |
| Submitter's Telephone: | 574-267-0864 |
| Contact Person: | Yan Li yli@orthopediatrics.com |
| Date Summary was Prepared: | December 4, 2020 |
| Trade or Proprietary Name: | RESPONSE™ Navigation Instruments |
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The OrthoPediatrics RESPONSE™ Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.
The RESPONSE™ Navigation Instruments include taps, probes, and drivers. The RESPONSE™ Navigation Instruments are to be used with the RESPONSE™ Spine System.
All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø3mm to Ø8mm. The RESPONSE™ 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
RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® Stealthstation® S8 System (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be
5
Image /page/5/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child's face with a smile, with the word "Ortho" written in blue next to the face. The word "Pediatrics" is written in red to the right of "Ortho". There is a registered trademark symbol next to the word "Pediatrics".
appropriate, and where reference to a rigid anatomical structure, such as 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
- Materials of manufacture
- Principles of Operation ●
- Sizes
| 510k Number | Trade/Proprietary/Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K161210/K143628 | Medtronic Navigated Instruments | Medtronic Sofamore | Primary |
| K140454/K143375 | Danek USA, Inc. | ||
| K193100/K181390 | RESPONSE™ Spine System | OrthoPediatrics, Corp. | Reference |
| K160466/K150600 |
PERFORMANCE DATA
A detailed dimensional analysis and comparison has been conducted for subject and predicate device to support the substantial equivalence.
Additionally, the RESPONSE™ Navigation Instruments have been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems".
- . Single point measurement accuracy per ASTM F2554-18
- Instrument axis rotation measurement accuracy per ASTM F2554-18
- . Instrument angular position perpendicular to the system camera measurement accuracy per ASTM F2554-18
- . Instrument angular position parallel to the system camera measurement accuracy per ASTM F2554-18
- . Distance between points measurement accuracy per ASTM F2554-18
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Image /page/6/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a smiling face with a body and arm made of a green arrow. The text "OrthoPediatrics" is written in a playful, handwritten font, with "Ortho" in blue and "Pediatrics" in red.
The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the RESPONSE™ Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the RESPONSE™ Navigation Instruments is substantially equivalent to the predicate device.