RESPONSE Navigation Instruments

K203573 · OrthoPediatrics Corp. · OLO · Feb 4, 2021 · Neurology

Device Facts

Record IDK203573
Device NameRESPONSE Navigation Instruments
ApplicantOrthoPediatrics Corp.
Product CodeOLO · Neurology
Decision DateFeb 4, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 882.4560
Device ClassClass 2

Intended 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® 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.

Device Story

Reusable surgical instruments (taps, probes, drivers) used in open spinal surgery; designed for use with Medtronic StealthStation S8 Navigation System. Instruments track anatomical structures to assist in pedicle screw preparation and placement. Surgeon operates instruments manually while system provides navigation feedback via CT/MR/fluoroscopy/digitized landmarks. Output allows surgeon to precisely locate vertebrae; facilitates accurate implant placement; potentially improves surgical outcomes by enhancing navigation accuracy. Used in clinical OR settings.

Clinical Evidence

Bench testing only. Performance evaluated via dimensional analysis and testing per ASTM F2554-18 (Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems). Metrics included single point measurement accuracy, instrument axis rotation accuracy, instrument angular position accuracy (perpendicular and parallel to camera), and distance between points measurement accuracy.

Technological Characteristics

Reusable stainless steel instruments (ASTM F899). Includes taps (Ø3mm-Ø8mm), probes, and drivers. Operates as passive navigation markers for use with Medtronic StealthStation S8 System. Connectivity is hardware-dependent on the navigation system. Sterilization method not specified. No internal software; relies on external navigation system software.

Indications for Use

Indicated for use during spinal surgery for the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws in open procedures to assist surgeons in locating anatomical structures. Used with Medtronic S8 System for conditions requiring stereotactic surgery where rigid anatomical structures (e.g., vertebrae) are referenced against CT, MR, fluoroscopy, or digitized landmarks.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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) | |-------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> <span style="font-size: 10px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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." {4}------------------------------------------------ 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 {6}------------------------------------------------ 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.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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