(28 days)
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.
The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
The Stimulating Bur Guard is a sterile, single use device used in conjunction with the XPS 3000 BF Powered Drill System and the Medtronic Xomed Nerve Monitoring System. It locks onto a handpiece and has an opening on the anterior end to accept a standard bur / blade. The primary purpose of the Stimulating Bur Guard is to deliver the stimulating current from the Nerve Monitoring console to the standard bur / blade on the drill handpiece. The second purpose of the Stimulating Bur Guard is to provide support for the extended length burs.
Here is an analysis of the provided 510(k) summary regarding the Stimulating Bur Guard, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Generalized from text) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliant with ISO 10993-1:2003 and FDA G95-1 for external communicating devices with tissue/bone contact < 24 hrs. | The device is considered biocompatible and "appropriate tests were performed on all patient contacting materials." Specific results not detailed. |
| Shelf Life Aging | Three (3) months shelf life required for limited market release; minimum one (1) year at full market release; ultimately achieve four (4) year shelf life. | "Accelerated aging studies for the Stimulating Guard will ensure three (3) months shelf life prior to a limited market release." (Future projections for full market release and beyond.) |
| Operating Life | The device must meet acceptance criteria for worst-case use during a surgical procedure for single-use. | "The device met the acceptance criteria for worst case use during a surgical procedure." |
| Bench Testing | Specific criteria for: Reliability and Useful life, Bur/blade Compatibility, Current delivery, Current delivery compared to 2.3mm ball tip probe, Noise, Temperature, Current drop out, Electrical Isolation. | "The device met the acceptance criteria for: Reliability and Useful life, Bur / blade Compatibility, Current delivery, Current delivery compared to 2.3mm ball tip probe, Noise, Temperature, Current drop out, Electrical Isolation." Specific values/results not detailed. |
| EMC & Electrical Safety | System (Stimulating Guard + nerve monitoring + drill system consoles) compliance with EN 60601-1-2 (EMC) and EN / IEC 60601-1 (Electrical Safety). | "The devices are evaluated for EMC as a system... in accordance with EN 60601-1-2. Electrical safety testing is conducted in accordance with EN / IEC 60601-1." "Both the XPS 3000 and NIM systems are BF rated." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical or performance data from human subjects. The studies described are primarily bench testing and biocompatibility testing.
- Bench Testing: No sample size is explicitly stated for the number of devices or tests performed in areas like reliability, current delivery, or noise.
- Biocompatibility: No sample size of materials or tests is explicitly stated, beyond "all patient contacting materials."
- Data Provenance: The studies are described as bench testing and laboratory studies (biocompatibility, shelf life). There's no mention of human subject data, retrospective or prospective, or country of origin for such data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The device is a surgical accessory, and the studies described are technical performance evaluations, not clinical studies requiring expert ground truth for interpretation of outcomes or images.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies, especially those involving expert interpretation of data (e.g., imaging studies), which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. Such studies are generally conducted for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI on human reader performance, which doesn't apply to this surgical stimulating bur guard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are essentially standalone performance evaluations of the device's physical and electrical properties. There is no "algorithm" in the sense of AI or software interpreting data for human users. The device itself is an accessory to existing systems (Nerve Integrity Monitor and XPS Drill Systems). The various bench tests directly assess the device's intended function and safety characteristics in a standalone manner (though in conjunction with the specified predicate systems for electrical tests).
7. The Type of Ground Truth Used
The "ground truth" for the various tests described would be based on:
- Bench Test Specifications: Pre-defined engineering specifications, electrical standards, and performance limits for parameters like current delivery, noise, temperature, and reliability.
- Regulatory Standards: Compliance with ISO and FDA biocompatibility standards.
- Manufacturer's Internal Standards: For shelf life and operating life tests, likely based on internal validation protocols.
Essentially, the ground truth is derived from objective engineering and regulatory standards, rather than clinical outcomes, pathology, or expert consensus on clinical data.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device does not use an "algorithm" or "AI" that requires a training set. The descriptions relate to traditional device verification and validation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided as there is no training set for this device.
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510(k) Summary
NOV 2 9 2006
| 510(k) Owner | Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX) |
|---|---|
| Contact Name | Antoine KouchakjySenior Regulatory Affairs SpecialistMedtronic Xomed, Inc |
| Date Summary Prepared | October 31, 2006 |
| Proprietary Name | Stimulating Bur Guard (Final name TBD) |
| Common Name | Stimulator, Nerve |
| Classification Name | Primary · Surgical nerve stimulator / locator(21 CFR 874.1820, Product Code ETN, Class II)Secondary · Drill, Surgical, ENT (electric or pneumatic) includinghandpiece(21 CFR 874.4250, Product Code ERL, Class II)Secondary · Surgical instrument motors & accessories / attachments(21 CFR 878.4820, Product Code HWE, Class I) |
Marketed device claiming equivalence to:
The Stimulating Bur Guard is equivalent to the Medtronic Xomed Monopolar Stimulator Probe, K992869. The guard is also an accessory to the XPS 3000 Drill System covered under K041523.
Device Description
The Stimulating Bur Guard is a sterile, single use device used in conjunction with the XPS 3000 BF Powered Drill System and the Medtronic Xomed Nerve Monitoring System. It locks onto a handpiece and has an opening on the anterior end to accept a standard bur / blade. The primary purpose of the Stimulating Bur Guard is to deliver the stimulating current from the Nerve Monitoring console to the standard bur / blade on the drill handpiece. The second purpose of the Stimulating Bur Guard is to provide support for the extended length burs.
Intended Use
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.
Page 9 of 298
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Image /page/1/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K063305". The characters are written in a cursive style, with some connections between the numbers.
Indications for Use
The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
| Characteristic | New Device:Medtronic XomedStimulating Guard | Predicate:Medtronic Xomed Ball-TipMonopolar StimulatingProbe [K992869] |
|---|---|---|
| Intended use | When used with both the MedtronicNerve Integrity Monitor (NIM) andXPS Drill Systems, the StimulatingGuard is intended to stimulate cranialand peripheral motor nerves,including spinal nerve roots, with astandard bur / blade for location andidentification during the incision andremoval of soft and hard tissue orbone. | To stimulate cranial andperipheral motor nerves forlocation and identificationduring surgery, includingspinal nerve roots |
| Insulated | Yes | Yes |
| Stimulator connector | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization Method | ETO | ETO |
| Shelf Life | 3 months (initially) | 8-year |
| Single Use | Yes | Yes |
| Monopolar | Yes | Yes |
Summary of Technological Characteristics
Biocompatibility
The Stimulating Guard is considered biocompatible for use as an external communicating device with tissue / bone contact of limited duration (< 24 hrs). The appropriate tests were performed on all patient contacting materials according to:
- ISO 10993-1:2003, Biological evaluation of medical devices Part 1 Evaluation . and Testing
- FDA G95-1, Required Biocompatibility Training and Toxicology Profiles for . Evaluation of Medical Devices, May 1, 1995
Shelf Life Aging
Accelerated aging studies for the Stimulating Guard will ensure three (3) months shelf life prior to a limited market release and a minimum shelf life of one (1) year at the time of full market release. Shelf life testing will be ongoing post-launch to ultimately achieve a four (4) year shelf life.
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KOG 3305
Operating Life
The device is provided sterile and intended for single use. No reprocessing instructions are given. The device met the acceptance criteria for worst case use during a surgical procedure.
Bench Testing
The device met the acceptance criteria for: Reliability and Useful life, Bur / blade Compatibility, Current delivery, Current delivery compared to 2.3mm ball tip probe, Noise, Temperature, Current drop out, Electrical Isolation
Electromagnetic Compatibility and Electrical Safety Testing
The Stimulating Guard is not a source of electromagnetic interference in and of itself. However, the devices are evaluated for EMC as a system with the nerve monitoring and drill system consoles in accordance with EN 60601-1-2. Electrical safety testing is conducted in accordance with EN / IEC 60601-1 and electrical safety is achieved through levels of protection built within the BF Rated Consoles. Both the XPS 3000 and NIM systems are BF rated.
Software
The device does not contain any software nor does it require any software changes to be made to the XPS Drill System or the Nerve Monitoring System (NIM)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Xomed, Inc. c/o Antoine Kouchakiy Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216-0980
NOV 2 9 2006
Re: K063305
Trade/Device Name: Stimulating Bur Guard Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: October 31, 2006 Received: November 1, 2006
Dear Mr. Kouchakjy:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Antoine Kouchakjy
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychlemin IWD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Kolo 3305 510(k) Number (if known):
Stimulating Bur Guard (Final name to be determined) Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the When used with bour the modified North late cranial and peripheral motor nerves, including Stimulating Dur Guard is meenated bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.
The Stimulating Bur Guard is indicated for nerve monitoring the incision and removal of The Stimulating Dur Guard is marcated bur / blade during otology, neurotology, sinus, Son and hard though of oche wad neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth Baker
510(k) Number K063305
Prescription Use
(Per 21 CFR 801.109) X
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§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.