K Number
K971544
Device Name
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
Manufacturer
Date Cleared
1997-05-28

(30 days)

Product Code
Regulation Number
878.4820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions.
Device Description
The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories. Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments.
More Information

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No
The description focuses on the mechanical aspects and functions of an air-powered drill, with no mention of AI or ML capabilities.

No
The device is described as an air-powered drill used for various surgical mechanics (drilling, reaming, sawing, etc.) and is equivalent to predicate drill devices. Its function is to perform mechanical actions, not to cure, mitigate, treat, or prevent disease.

No

The device description indicates it is a surgical tool used for mechanical functions (drilling, reaming, sawing, etc.), not for diagnosing medical conditions.

No

The device description clearly states it is an "air powered drill" and lists various hardware components and accessories, indicating it is a physical medical device, not software-only.

No, the Synthes CAD II is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use/Indications for Use: The description clearly states its use is for surgical procedures involving drilling, reaming, sawing, burring, filing, and screwdriving. These are mechanical actions performed directly on tissue or bone.
  • Device Description: The description details a mechanical air-powered drill with various attachments for surgical manipulation. There is no mention of analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Synthes CAD II does not perform any such analysis.

The Synthes CAD II is a surgical instrument used for mechanical manipulation during procedures.

N/A

Intended Use / Indications for Use

Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions.

Product codes

HWE

Device Description

The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories.
Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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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)

Based on the mechanical test results, Synthes CAD II is at least equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

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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/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. The logo and the word are the only elements in the image. The word "SYNTHES" appears to be a brand name or company name.

K971544

Attachment IX:

Summary of Safety and Effectiveness Information

Synthes (USA) 1690 Russell Road Paoli, PA 19301

Contact: Sheri L. Musgnung (610) 647-9700 April 1997

Synthes Compact Air Drive II (CAD II) is compared to Synthes Small Air Drill (SAD) and Synthes Universal Air Drill (UAD).

The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories.

The Synthes SAD and UAD is also used for drilling, reaming, burring, and screwdriving functions and accepts a variety of attachments and accessories.

Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments.

Based on the mechanical test results, Synthes CAD II is at least equivalent to the predicate devices.

1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1997

Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes (USA) -- - - -1690 Russell Road PO Box 1766 Paoli, Pennsylvania 19301

Re: K971544

Trade Name: Synthes (USA) Compact Air Drive II (CAD II) Regulatory Class: I Product Code: HWE Dated: April 25, 1997 Received: April 28, 1997

Dear Ms. Musgnung:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further ansouncements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sheri L. Musgnung

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.

SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions.

(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 Devices
510(k) NumberK971544

| Prescription Use

(Per 21 CFR 801.109)X
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OR

Over-The-Counter Use
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