INSURGICAL SINGLE USE POWER EQUIPMENT

K112599 · Insurgical, LLC · KIJ · Nov 6, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K112599
• Device Name: INSURGICAL SINGLE USE POWER EQUIPMENT
• Applicant: Insurgical, LLC
• Product Code: KIJ · General, Plastic Surgery
• Decision Date: Nov 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Insurgical TM Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

Device Story

Insurgical Single Use Power Equipment consists of battery-powered surgical handpieces (drill, orthopedic reamer) and attachments. System uses rechargeable DC batteries; handpieces and attachments are single-use and provided sterile. Operated by surgeons in clinical/surgical settings for orthopedic, reconstructive, and trauma procedures. Device features trigger lock for safe accessory attachment. Output is mechanical rotation for cutting, drilling, reaming, and smoothing bone or metal. Benefits include single-use sterility for handpieces, reducing cross-contamination risk, while utilizing reusable battery power.

Clinical Evidence

No clinical data. Evidence consists of bench testing: IEC 60601-1-2 (EMC), CISPR 11 (RF emissions), IEC 61000-4-2 (ESD), IEC 61000-4-3 (RF immunity), UL1642 (battery safety), ISO 10993-5 (cytotoxicity), cadaveric simulated use, and laboratory validation of aseptic battery transfer.

Technological Characteristics

DC-powered hand-held surgical motor system. Components: drill, reamer, attachments, rechargeable batteries. Features: trigger lock. Standards: IEC 60601-1-2, CISPR 11, IEC 61000-4-2/3, UL1642, ISO 10993-5. Sterilization: Pre-sterilized (handpieces/attachments).

Indications for Use

Indicated for use in cutting, drilling, decorticating, and smoothing bone and bone-related tissue, and for placement or cutting of fixation devices (screws, wires, pins) and metal in surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Stryker System 4000 Heavy Duty Battery Powered Equipment (K972367)

Submission Summary (Full Text)

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K 1125.99 Page lot 3

**NOV**

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# 510(k) Summary Pursuant to 21 CFR 807.92

#### Date of preparation: November 5, 2012

- Insurgical, LLC Submitted By: 1. 9600 Great Hills Trail, Suite 150W Austin, Texas 78759
- David C. Furr 2. Contact: FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733 512-906-9654
- Insurgical™ Single Use Power Equipment Product: 3. Unclassified Product Code: KIJ
- 4. Common/Trade Name:

Instrument, Surgical, Orthopedic, DC Powered Motor and Accessory/Attachment

Insurgical™ Single Use Power Equipment

#### Description:

The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer.

Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.

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K112599 Page 2 of 3

#### Intended Use:

Insurgical TM Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

## Testing and Technological Characteristics:

The Insurgical™ Single Use Power Equipment System includes DC powered components with accessories. The devices are hand-held and provided sterile. They are for single use orthopedic surgical applications.

The handpieces include a trigger lock, which can be engaged to safely allow for attachment of accessories. The devices are powered by DC batteries, which are non-sterile and reusable.

The following testing was conducted with successful outcome to establish device safety and equivalence:

- IEC 60601-1-2 Medical Electrical Equipment/Part 1: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility
- CISPR 11 Industrial, scientific and medical (ISM) radio frequency . equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement
- IEC 61000-4-2 Electromagnetic Compatibility Part 4: Testing and . Measurement Techniques Section 2: Electrostatic Discharge Immunity Test
- IEC 61000-4-3 Electromagnetic Compatibility for Electrical and . Electronic Equipment, Part 3: Immunity to Radiated, Radio Frequency, Electromagnetic Fields
- Cadaveric simulated use test .
- Laboratory validation of aseptic battery transfer process .
- UL1642 Safety for Lithium Batteries .
- ISO 10993-5 Cytotoxicity .

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K112599 Page 3 of 3

## Substantial Equivalence:

The Insurgical Single Use Power Equipment is substantially equivalent to Stryker System 4000 Heavy Duty Battery Powered Equipment (K972367).

The predicate device has similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent.

## Conclusions:

The predicate device and the Insurgical Single Use Power Equipment share similar indications, technology, and application. The Insurgical product is equivalent to the predicate device products in key areas of performance that affect safety and effectiveness.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Insurgical, LLC % FDC Services, LLC Mr. David C. Furr Principal Consultant 8708 Capehart Cove Austin, Texas 78733

November 6, 2012

Re: K112599

Trade/Device Name: Insurgical™ Single Use Power Equipment Regulatory Class: Unclassified Product Code: KIJ Dated: October 03, 2012 Received: October 10, 2012

Dear Mr. Furr:

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 – Mr. David C. Furr

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Insurgical Single Use Power Equipment

Page 1 of 1:

# Indications for Use Statement

510(k) Number:

K112599

Device Name:

Insurgical™ Single Use Power Equipment

Indications for Use:

Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

Prescription Use X Over-the-counter use Or (per CFR 801.109)

Concurrence of CDRH

(Digital Sign Off)

(Division Sign On) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112595