(59 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on mechanical and functional aspects of navigated instruments and fixation devices, not AI/ML capabilities.
No
The device, Spinous Process Clamps, is an accessory designed to provide rigid attachment between a patient and a patient reference frame for the duration of surgery in conjunction with a StealthStation™ Navigation System. It is an instrument used to facilitate stereotactic surgery, not to treat a medical condition directly.
No.
The device is described as an instrument for surgical navigation and fixation, intended to provide rigid attachment during surgery, not to diagnose a medical condition.
No
The device description explicitly states "The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery." and describes physical testing like "Functional Verification", "Useful Life Testing", and "Packaging Verification", 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 description clearly states that the device is a "navigated instrument" and "Spine Referencing fixation device" used with a navigation system during surgery. Its purpose is to provide rigid attachment to the patient's anatomy for navigation.
- Intended Use: The intended use is for stereotactic surgery where reference to rigid anatomical structures is needed for navigation. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The device description focuses on its function as a clamp for rigid attachment during surgery.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with in vitro diagnostics.
Therefore, the device described is a surgical instrument used for navigation during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The navigated instruments are specifically designed for use with the 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 skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the StealthStation™ System and are intended to be reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Testing Activity: Functional Verification
Description: Confirms that the Spinous Process Clamp design satisfies functional requirements.
Performance Testing Activity: Useful Life Testing
Description: Confirms that the Spinous Process Clamps can operate normally throughout their useful life.
Performance Testing Activity: Navigation Accuracy Testing
Description: Verifies the robustness and navigational accuracy of the Spinous Process Clamps.
Performance Testing Activity: Packaging Verification
Description: Confirms that the Spinous Process Clamps when packaged in their packaging can withstand ship testing per ASTM D4169 and ISTA 2A.
Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1:2018, indicates that the subject devices are non-cytotoxic, non-sensitizing, nonirritating, non-toxic, and non-pyrogenic and pose a negligible risk of adverse biological effects to patients when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
July 8, 2021
Image /page/0/Picture/1 description: The image contains 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 logo 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.
Medtronic Navigation Victoria Baldock Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K211442
Trade/Device Name: StealthStation Spinous Process Clamps Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 7, 2021 Received: May 10, 2021
Dear Victoria Baldock:
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 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
1
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,
For: 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
2
Indications for Use
510(k) Number (if known) K211442
Device Name StealthStation™ Spinous Process Clamps
Indications for Use (Describe)
The navigated instruments are specifically designed for use with the 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 skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Ref 21 CFR 201 Subpart D) | X |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Page 1 of 4
510(k) Summary
May 07, 2021
l. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3500
Contact: Victoria Baldock Associate Regulatory Affairs Specialist Telephone Number: (423) 863-5907 Email: tori.a.baldock@medtronic.com
Rishi Sinha (Alternate) Regulatory Affairs Director Telephone Number: (720) 890-2485 Email: rishi.k.sinha@medtronic.com
- Proprietary Trade Name: StealthStation™ Spinous Process Clamps II.
- lll. Common Name: Orthopedic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II
- VI. Product Code: OLO (Stereotaxic Instrument)
VII. Predicate Devices:
The legally marketed predicate devices are identified below:
| Predicate | 510(k) Clearance |
|---|---|
| Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter | K131425 |
VIII. Product Description:
The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the StealthStation™ System and are intended to be reusable.
IX. Indications for Use:
The navigated instruments are specifically designed for use with the 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 skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
4
When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.
X. Comparison of the Technological Characteristics:
The subject Spinous Process Clamps (Generation 4) utilize the same fundamental scientific technology and have the same mode of operation and functionality as the predicate Spinous Process Clamps (Generation 2) (K131425). The subject devices have equivalent materials and sterilization/reprocessing methods as the predicate (K131425). The changes in design features between the subject and the predate do not raise any new risks or any concerns about the safety and effectiveness. The subject devices also meet the established navigational accuracy requirements.
| Feature | Subject Devices
StealthStation™ Spinous
Process Clamps | Predicate Devices
Navigated CAPSTONE®
Trials, CLYDESDALE®
Trials, and CAPSTONE®
& CLYDESDALE®
Inserter (K131425) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | When used with a
Medtronic StealthStation™
Navigation System, the
Spine Referencing fixation
devices are intended to
provide rigid attachment
between patient and patient
reference frame for the
duration of the surgery. The
devices are intended to be
reusable. | When used with a
Medtronic StealthStation™
Navigation System, the
Spine Referencing fixation
devices are intended to
provide rigid attachment
between patient and
patient reference frame for
the duration of the surgery.
The devices are intended
to be reusable. |
| Indications for Use | The navigated instruments
are specifically designed for
use with the
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 skull, a long bone, or
vertebra can be identified
relative to a CT or MR
based model, fluoroscopy
images, or digitized
landmarks of the anatomy. | The navigated instruments
are specifically designed
for use with the
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 skull, a long bone, or
vertebra can be identified
relative to a CT or MR
based model, fluoroscopy
images, or digitized
landmarks of the anatomy. |
Table 1. Comparison of Technological Characteristics
5
| Sterilization Method | Non-sterile, Steam sterilization, Reusable | Non-sterile, Steam sterilization, Reusable |
|---|---|---|
| Material | Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel | Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel |
| Thread Relief | Screw engaged threads with clamping mechanism at all time, due to full threaded screw design. Removal of two washer components due to screw changes. | Unengaged screw when clamps are open, due to thread relief in screw design. |
| Jaw Shape | Single Clamps: Concave shape of jaws to align to the spinous process bulbous top | |
| Double Clamps: Non-concave | Single Clamps: Non-concave | |
| Double Clamps: Non-concave | ||
| Teeth | Single Clamps: Small teeth on the upper (concave) part of jaws, same size teeth as predicate on lower part of jaws | |
| Double Clamps: Teeth all same size | Single Clamps: Teeth all same size | |
| Double Clamps: Teeth all same size | ||
| Distal End Shape | Single Clamps: Pointed jaw at distal end | |
| Double Clamps: Blunt jaw at distal end | Single Clamps: Blunt jaw at distal end | |
| Double Clamps: Blunt jaw at distal end | ||
| Clamping Range | Single Clamps: 11 mm | |
| Double Clamps: 9 mm | Single Clamps: 9 mm | |
| Double Clamps: 9 mm | ||
| Size Offerings | Short, Medium, and Tall | Short and Tall |
XI. Discussion of the Performance Testing:
Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows:
| Performance Testing
| Activity | Description |
|---|---|
| Functional Verification | Confirms that the Spinous Process Clamp design |
| satisfies functional requirements. | |
| Useful Life Testing | Confirms that the Spinous Process Clamps can |
| operate normally throughout their useful life. |
6
| Navigation Accuracy Testing | Verifies the robustness and navigational accuracy of
the Spinous Process Clamps. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Packaging Verification | Confirms that the Spinous Process Clamps when
packaged in their packaging can withstand ship
testing per ASTM D4169 and ISTA 2A. |
Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1:2018, indicates that the subject devices are non-cytotoxic, non-sensitizing, nonirritating, non-toxic, and non-pyrogenic and pose a negligible risk of adverse biological effects to patients when used as intended.
XII. Conclusion:
The subject devices have shown through comparison to be substantially equivalent to the identified predicate.