(90 days)
Not Found
No
The 510(k) summary describes reusable surgical instruments used with a navigation system. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself might utilize AI/ML, but the submitted device (the XL Instruments) does not appear to incorporate these technologies.
No
The device consists of instruments used during surgical preparation and placement of screws, designed to assist the surgeon in locating anatomical structures. It is not described as directly treating a medical condition itself.
No
Explanation: The device is a set of surgical instruments used for navigation during surgery, not for diagnosing medical conditions. Its purpose is to assist in "precisely locating anatomical structure" during surgical procedures.
No
The device description explicitly lists physical instruments (Cannulated Screwdriver, Cannulated Pedicle AWL, etc.) and describes them as reusable, autoclavable, and intended for manual use in a sterile environment. This indicates a hardware component, not a software-only device.
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 intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Premia Spine XL Instruments are surgical instruments used during surgery to assist the surgeon in precisely locating anatomical structures (vertebrae) using a navigation system. They are used directly on the patient's body during a procedure, not for testing specimens outside the body.
- Intended Use: The intended use clearly states they are for use "during the preparation and placement of Premia Spine screws during surgery" and to "assist the surgeon in precisely locating anatomical structure." This is a surgical aid, not a diagnostic test.
The device is a surgical instrument that utilizes imaging data (CT, MR, fluoroscopy) and a navigation system to guide surgical procedures. This falls under the category of surgical navigation or guidance systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures.
Premia Spine XL Instruments 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or diqitized landmarks for the anatomy.
The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic's StealthStation Navigation System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The XL Instruments is comprised of seven instruments:
- Cannulated Screwdriver;
- Cannulated Pedicle AWL;
- Cannulated Pedicle Probe;
- Cannulated TAP XL 4.5, 5.5 and 6.5 mm;
- Straight Pedicle Probe.
The XL Instruments are reusable stereotaxic surgical instruments, designed to be used with the Medtronic StealthStation navigation system.
They are reusable (autoclavable) instruments, intended to be used in a sterile environment, and initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Surgery operating room
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
Bench testing was performed per the following voluntary performance standards or FDA guidance:
- Registering and calibration of the instruments on the StealthStation testing; ●
- Failure mode testing; ●
- . Interfacing of each instrument with the StealthStation testing, per ASTM F-2554;
- Equivalence of the pre-submitted geometric properties of the predicate and subject devices.
All tests met the predefined acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed. All tests met the predefined acceptance criteria. Performance testing has demonstrated that the XL Instruments set is as safe and effective as the predicate.
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
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October 8, 2019
Premia Spine, Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103
Re: K191854
Trade/Device Name: Premia Spine XL Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 10, 2019 Received: July 10, 2019
Dear Janice Hogan:
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.
1
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 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, MPH 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
2
510(k) Number (if known)
K191854
Device Name
Premia Spine XL Instruments
Indications for Use (Describe)
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures.
Premia Spine XL Instruments 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or diqitized landmarks for the anatomy.
The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic's StealthStation Navigation System.
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
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3
K191854 Premia Spine Ltd.'s XL Instruments
1. Submitter's Identification
Premia Spine Ltd. 7 Giborey Israel Street Ramat Poleg, 42504 Israel Phone: +972-72-228-1200 Contact Person: Ron Sacher
Date Prepared: October 7, 2019
2. Name of Device
Name of Device: XL Instruments Common or Usual Name: XL navigation instruments Classification: 21 CFR 882.4560 Classification Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Product Code Name: Orthopedic Stereotaxic Instrument
3. Predicate and Reference Device Information
Predicate: K153442, Medtronic Navigated Reusable Instruments for Use with the StealthStation® and IPC® Powerease™ Systems
4. Device Description
The XL Instruments is comprised of seven instruments:
- · Cannulated Screwdriver;
- Cannulated Pedicle AWL;
- · Cannulated Pedicle Probe;
- · Cannulated TAP XL 4.5, 5.5 and 6.5 mm;
- · Straight Pedicle Probe.
The XL Instruments are reusable stereotaxic surgical instruments, designed to be used with the Medtronic StealthStation navigation system.
They are reusable (autoclavable) instruments, intended to be used in a sterile environment, and initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use.
5. Indications for Use
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures.
4
Premia Spine XL Instruments 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic's StealthStation Navigation System.
6. Summary of Technological Characteristics and Comparison
The clinical set-up and mode of operation of the subject device are similar to the proposed predicate (K153442).
Both the predicate and the subject devices are composed of several instruments designed to be registered and then identified by the Medtronic StealthStation to allow the surgeon using them to precisely locate anatomical structures during stereotaxic surgical procedures.
The principles of operation of the XL instruments are identical to those of the predicate.
The technical specifications of the subject and predicate devices are similar. The system features sufficiently equivalent geometries to the predicate such that the performance of the subject and predicate devices are equivalent.
| Parameter | XL Instruments | Medtronic Instruments |
|---|---|---|
| Indication for | ||
| Use | Premia Spine XL Instruments are | |
| intended to be used during the | ||
| preparation and placement of Premia | ||
| Spine screws during surgery to assist | ||
| the surgeon in precisely locating | ||
| anatomical structure in either open or | ||
| minimally invasive procedures. | Medtronic Navigated Reusable | |
| Instruments are intended to be used | ||
| during the preparation and placement of | ||
| Medtronic screws during spinal surgery | ||
| to assist the surgeon in precisely | ||
| locating anatomical structures in either | ||
| open, or minimally invasive, | ||
| procedures. | ||
| Premia Spine XL Instruments 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 vertebra, can be | ||
| identified relative to a CT or MR based | ||
| model, fluoroscopy images, or digitized | ||
| landmarks for the anatomy. | Medtronic Navigated Reusable | |
| 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 XL Instruments are nonsterile | ||
| instruments that can be used manually. | ||
| These instruments are intended to be | ||
| used with the Medtronic's | ||
| StealthStation Navigation System. |
5
| Parameter | XL Instruments | Medtronic Instruments |
|---|---|---|
| Class | II | II |
| Regulation | 21 CFR §882.4560 | 21 CFR §882.4560 |
| Code | OLO | OLO |
| 510k number | Subject | K153442 |
| Environment | Surgery operating room | Surgery operating room |
| Prescription | Rx Prescription | Rx Prescription |
| Critical dimensions | Identical for Tap 4.5 mm, Tap 5.5 mm, Tap 6.5 mm, Pedicle awl, Pedicle probe; | |
| Equivalent for screwdriver | ||
| Instrument Registration | Identical | |
| Instrument Calibration | Identical | |
| Instrument Interface | Identical | |
| Tracking method | Identical | |
| Material | Stainless steel | Stainless steel |
| Sterilization | To be steam sterilized before use | To be steam sterilized before use |
Table VII-1: Comparison Table
7. Summary of Performance Data
Bench testing was performed per the following voluntary performance standards or FDA guidance:
- Registering and calibration of the instruments on the StealthStation testing; ●
- Failure mode testing; ●
- . Interfacing of each instrument with the StealthStation testing, per ASTM F-2554;
- Equivalence of the pre-submitted geometric properties of the predicate and subject devices.
All tests met the predefined acceptance criteria.
8. Conclusions
The XL Instruments set has the same intended use and the same basic technological characteristics of the predicate device, Medtronic Navigated Reusable Instruments for Use with the StealthStation® and IPC® Powerease™ Systems. The differences of geometry between the subject and the predicate devices are supported by the comparison testing and do not raise different questions of safety and effectiveness. Performance testing has demonstrated that the XL Instruments set is as safe and effective as the predicate. Therefore, the XL Instruments set is substantially equivalent to the predicate device.