(30 days)
Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
The Microspeed Uni is an electronic, high-speed motor system, which allows high-speed dissection up to 80,000 rpm while also allowing low speed cutting up to 40,000 rpm. The control system reduces heating to a minimum at high torque. The low speed motor can make use of all Aesculap Intra-handpieces (K953968) for adapted power at minimum weight. All HiLAN (K980686 and K973736) and Microspeed (K003612) handpieces can also be used for high-speed dissection with the Microspeed Uni. This allows universal use of one motor system during the entire procedure. All functions of the Microspeed Uni can be controlled from the sterile field by the foot control as well as the hand control for easy handling.
The Microspeed Uni Motor System is a medical device. The provided text indicates that the device's substantial equivalence was demonstrated by compliance with recognized consensus standards. Therefore, an in-depth study of the device’s performance against acceptance criteria as might be seen for a novel AI/ML device is not explicitly described in the provided text.
Here's an analysis based on the information given, framed to address your request for acceptance criteria and study details where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device must meet general safety requirements for medical electrical equipment. | Complies with IEC60601-1 and UL2601-1. |
| Electromagnetic Compatibility: Device must meet requirements for electromagnetic compatibility. | Complies with IEC60601-1-2. |
| Canadian Safety Standards: Device must meet Canadian medical electrical equipment safety standards. | Complies with CAN/CSA-C22.2 No. 601.1-M90. |
| Substantial Equivalence: Device must demonstrate substantial equivalence to predicate devices regarding operating speeds, power sources, attachments, and materials. | The device offers similar operating speeds, power sources, and attachments as the predicate devices (Aesculap Microspeed EC (K003612) and Stryker Total Performance System (K943589)). Materials used are the same or similar as those in predicate devices. |
| Intended Use: Device must be suitable for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in Spine, ENT, Neuro, and Maxillofacial Surgery. | Indicated for these uses, consistent with the functions of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes compliance with recognized standards and comparison to predicate devices, not a clinical trial with a test set of data in the context of AI/ML performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this type of device is established through engineering and safety standard compliance, and comparison to existing, legally marketed predicate devices, not expert consensus on data interpretation.
4. Adjudication Method for the Test Set
Not applicable. There was no test set of data requiring adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an electric surgical motor system and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm; it is a physical surgical motor system.
7. The Type of Ground Truth Used
The ground truth or basis for acceptance relies on:
- Compliance with recognized consensus standards: This serves as an objective measure of safety and performance against established engineering and electrical standards.
- Substantial equivalence to legally marketed predicate devices: This implies that the device's performance is deemed acceptable because it is functionally similar to devices already found safe and effective by the FDA.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for an AI/ML algorithm.
Summary of the Study:
The "study" or justification for the device's acceptance is primarily a comparison to predicate devices and compliance with international and national safety and performance standards.
- Predicate Devices: The Microspeed Uni Motor System was compared to the Aesculap Microspeed EC (K003612) and the Stryker Total Performance System (K943589).
- Technological Characteristics: The manufacturer stated that the Microspeed Uni offers "similar operating speeds, power sources, and attachments" and uses "the same or similar" materials as the predicate devices.
- Performance Data/Standards Compliance: Although no specific performance standards under Section 514 of the Food, Drug and Cosmetic Act were promulgated for this device type at the time, the device demonstrated compliance with several recognized consensus standards:
- IEC60601-1: General requirements for safety of medical electrical equipment.
- IEC60601-1-2: Electromagnetic compatibility requirements and tests for medical electrical equipment.
- UL2601-1: General safety requirements for medical electrical equipment.
- CAN/CSA-C22.2 No. 601.1-M90: Canadian standard for general safety requirements for medical electrical equipment.
This approach, known as 510(k) premarket notification, relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, often by showing it meets the same functional and safety benchmarks as those predicates, or complies with relevant recognized standards. The FDA's letter (K053526) confirms that substantial equivalence was determined based on the information provided, allowing the device to be marketed.
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JAN 1 8 2006
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
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Microspeed Uni Motor System December 16, 2005
- Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
- CONTACT: Kathy A. Racosky 800-258-1946 (phone) 610-791-6882 (fax) kathy.racosky@aesculap.com (email)
- TRADE NAME: Microspeed Uni Motor System
- COMMON NAME: Electric Surgical Motor System
- CLASSIFICATION NAME: Motor, Drill, Electric
- REGULATION NUMBER: 882.4360
- PRODUCT CODE: нвс
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Microspeed Uni Motor System is substantially equivalent to:
DEVICE DESCRIPTION
The Microspeed Uni is an electronic, high-speed motor system, which allows high-speed dissection up to 80,000 rpm while also allowing low speed cutting up to 40,000 rpm. The control system reduces heating to a minimum at high torque.
The low speed motor can make use of all Aesculap Intra-handpieces (K953968) for adapted power at minimum weight. All HiLAN (K980686 and K973736) and Microspeed (K003612) handpieces can also be used for high-speed dissection with the Microspeed Uni. This allows universal use of one motor system during the entire procedure.
All functions of the Microspeed Uni can be controlled from the sterile field by the foot control as well as the hand control for easy handling.
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INDICATIONS FOR USE
Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillofacial Surgery.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The Microspeed Uni Motor System offers similar operating speeds, power sources, and attachments as the predicate devices. The material used for the Aesculap Microspeed Uni Motor System is the same or similar as that used to manufacture the predicate devices.
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. Aesculap's Motor System, however, complies with the following standards which appear on the FDA list of Recognized Consensus Standards:
- IEC60601-1: International electrotechnical commission: Medical electrical equipment Part 1: general requirements for safety
- IEC60601-1-2: International electrotechnical commission: Medical electrical equipment Part 1: general requirements for safety; collateral standard: Electromagnetic compatibility - requirements and tests
- UL2601-1: Underwriters laboratories; medical electrical equipment, general requirements for safety
In addition, the Microspeed Uni Motor System meets the requirements of the following Canadian Standard Association standard.
CAN/CSA-C22.2 Medical Electrical Equipment, Part 1: General No. 601.1-M90 Requirements for Safety
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2006
Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K053526
Trade/Device Name: Microspeed Uni Motor System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: December 16, 2005 Received: December 21, 2005
Dear Ms. Racosky:
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. Racosky
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. INDICATIONS FOR USE STATEMENT
510(k) Number: KOS3526
Device Name: Microspeed Uni Motor System
Indications for Use:
Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K Os 5 26
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).