(35 days)
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No
The description focuses on mechanical and electrical aspects of a surgical handpiece, with no mention of AI or ML capabilities.
No
The device is described as a handpiece for holding and delivering power to surgical accessories like burrs and drills, used in surgical procedures. It is an instrument used to perform a modification on the body, rather than a device for treating a condition or disease.
No
The device is described as a surgical handpiece used for holding and delivering power to surgical accessories like burrs and drills, indicating an operative/therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "stainless steel device" and describes its physical dimensions and components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for holding and delivering power to surgical accessories (burrs, drills) for use in surgical procedures. This is a surgical tool used directly on a patient.
- Device Description: The description details a mechanical device for surgical use, connecting to a motor unit to power surgical accessories.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing biological samples outside of the body to provide diagnostic information. This device is a surgical instrument used within the body during a procedure.
N/A
Intended Use / Indications for Use
The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).
Product codes
Powered Surgical Instrument Systems, Surgical Instrument Motors and Accessories (per 21 CFR Section 878.4820)
Device Description
The only modification to the device is in the length of the handpiece shaft which has increased from 75mm to 125mm. Aesculap's modified Power System Handpiece is a stainless steel device used for holding and delivering power to surgical accessories (i.e. burrs, drills.) The device has an overall length of 230 mm with a shaft angle of 21°. The handpiece holds drills and burrs with a shank diameter of 2.35 mm and a length of 180 mm. The device is connected to an electro-surgical motor unit via a power drive cable. The Power System Handpiece is compatible with Aesculap's Elan-E and Microtron power units. The Internal gear ratio is 1:2, allowing the device to run at speeds of 0-36,000 rpm with the Elan-E and 0-54,000 rpm with the Microtron power unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device. However, the interface coupling on the Power System Handpiece meets the requirements of German DIN standard 13940 and International Standards Organization standard ISO 3964.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Image /page/0/Picture/1 description: The image shows the Aesculap logo. The logo consists of a symbol on the left and the word "AESCULAP" on the right. The symbol is a staff with a snake wrapped around it, inside of a circle, which is inside of a square. The word "AESCULAP" is in all caps and in a bold font.
MAR - 7 1996
Page 1 of 2
510(k) Summary of Safety and Effectiveness
(in Accordance with SMDA of 1990)
Aesculap Power System Handpiece
January 31, 1996
Aesculap®, Inc Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (415) 876-7000 x348 FAX: (415) 589-3007
Product Name
Trade Name: Common Name Classification Name:
Aesculap Power System Handpiece Powered Surgical Instrument Systems Surgical Instrument Motors and Accessories (per 21 CFR Section 878.4820)
Predicate Device
The Power System Handpiece presented in this application is a modification to an existing device. Aesculap's modified Power System Handpiece is compared to it's predecessor which is subject to #K770428. The modified Power System Handpiece is also compared to handpieces by Hall Surgical (#K864929) and Midas Rex (#K900388).
: 上一
Device Description
The only modification to the device is in the length of the handpiece shaft which has increased from 75mm to 125mm. Aesculap's modified Power System Handpiece is a stainless steel device used for holding and delivering power to surgical accessories (i.e. burrs, drills.) The device has an overall length of 230 mm with a shaft angle of 21°. The handpiece holds drills and burrs with a shank diameter of 2.35 mm and a length of 180 mm. The device is connected to an electro-surgical motor unit via a power drive cable. The Power System Handpiece is compatible with Aesculap's Elan-E and Microtron power units. The Internal gear ratio is 1:2, allowing the device to run at speeds of 0-36,000 rpm with the Elan-E and 0-54,000 rpm with the Microtron power unit.
VATEWAY BOULEVARD · SOUTH SAN FRANCISCO, · A 946,80-7030 · FAX: 415-876-7000 · FAX: 415-876-7028
1
Page 2 of 2
510(k) Summary of Safety and Effectiveness
(in Accordance with SMDA of 1990)
Aesculap Power System Handpiece
Intended Use
There has been no change in intended use for this modified device. The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).
Comparison of Technological Characteristics
Aesculap's Power System Handpiece is different from the predicate device from Aesculap only in the length of the shaft (increase from 75mm to 125mm). The shaft length is comparable to lengths offered by Hall Surgical and Midas Rex.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device. However, the interface coupling on the Power System Handpiece meets the requirements of German DIN standard 13940 and International Standards Organization standard ISO 3964.
Substantial Equivalence
Aesculap believes that the Power System Handpiece presented in this submission is substantially equivalent in design, function, and intended use to the presented devices from Aesculap, Hall Surgical and Midas Rex.