(70 days)
Not Found
No
The summary describes a pneumatically operated surgical instrument system with no mention of AI or ML capabilities.
Yes
The device is a surgical instrument system used for cutting, which directly treats conditions by performing surgical procedures.
No
The device is described as a surgical instrument system used for cutting and drilling, not for diagnosing medical conditions. Its intended uses are surgical procedures like craniotomy and spinal surgery.
No
The device description explicitly states it is a "pneumatic, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories," indicating it is a hardware-based system.
Based on the provided information, the Stryker Maestro Pneumatic system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument system used for cutting and operating on tissues within the body during surgical procedures. IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health.
- Device Description: The description details a pneumatic surgical instrument with a motor, hoses, and cutting accessories, consistent with a surgical tool, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Stryker Maestro Pneumatic system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Maestro Pneumatic system is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Product codes (comma separated list FDA assigned to the subject device)
HBB, ERL, EQL, HBE, DWH
Device Description
The Stryker Maestro Pneumatic System is a pneumatic, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
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)
Not Found
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.
Medtronic Legend®, Motor Drill Pneumatic (K020069)
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
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
041754
510(k) Summary
| Trade Name: | Stryker Maestro Pneumatic System |
|---|---|
| Common Name: | Surgical Drill motors with accessories |
| Classification: | Pneumatic cranial drill motors for neurosurgery (HBB) |
| Surgical drill for Ear, Nose, & Throat (ERL) | |
| Pneumatic cranial drill motor (HBB) | |
| Surgical Ear, Nose, & Throatbur (EQL) | |
| Powered simple cranial drill, burrs, and accessories (HBE) | |
| Blades, saw, surgical cardiovascular (DWH) | |
| Equivalent to: | Medtronic Legend®, Motor Drill Pneumatic (K020069), |
| Device Description: | The Stryker Maestro Pneumatic System is a pneumatic, high-speed |
| instrument system consisting of a motor (handpiece), hoses, and a | |
| variety of attachments and cutting accessories. | |
| Intended Use: | The Stryker Maestro Pneumatic System is a pneumatically operated |
| surgical instrument system. The pneumatic motor provides power to | |
| operate removable rotating surgical cutting tools and their accessories | |
| intended for use in neurosurgery, including craniotomy and spinal | |
| surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and | |
| general surgical applications including maxillofacial, craniofacial and | |
| sternotomy surgeries. | |
| Technological | |
| Comparison: | The Stryker Maestro Pneumatic System |
| has the same intended use as the Medtronic Legend®. This device | |
| and the predicate device have the same technological characteristics, | |
| the same operating principles, use the same patient contacting | |
| materials, and have similar performance characteristics. | |
| Conclusions: | Based upon the comparison to the predicate devices, the Stryker |
| Maestro Pneumatic System is substantially equivalent to legally | |
| marketed devices. | |
| Submitted by: | Nicole Petty |
| Stryker Instruments | |
| 4100 E. Milham Ave. | |
| Kalamazoo, MI 49001 | |
| 269-323-7700 | |
| Summary Prepared: | August 17, 2004 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping human profiles, often referred to as the "Human Services Symbol," which represents the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 7 2004
Ms. Nicole Petty Associate Manager, Regulatory Affairs Stryker Corporation Instrument Division 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K041754
Trade/Device Name: Stryker Maestro Pneumatic System Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: II Product Code: HBB Dated: August 17, 2004 Received: August 19, 2004
Dear Ms. Petty:
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 - Ms. Nicole Petty
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriàm C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
KO41754 510(k) Number Stryker Maestro Pneumatic System Device Name Indications The Stryker Maestro Pneumatic system is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
× Prescription Use (Per 21 CFR 801Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________