SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE

K063688 · The Anspach Effort, Inc. · HWE · Jan 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063688
• Device Name: SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
• Applicant: The Anspach Effort, Inc.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Jan 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

Device Story

Anspach Surgical Irrigation System is a stand-alone peristaltic pump and control system. It draws irrigation fluid from a standard IV bag and delivers it to an accessory for application at the surgical site. The system is used in clinical settings by surgeons to provide cooling during bone cutting, shaping, and removal (skull and spine). The subject of this modification is the irrigation tube component, which delivers fluid to a 1/16" OD accessory. Flow rate is determined by pump RPM and tubing dimensions. The device helps prevent thermal injury to bone during high-speed drilling or cutting.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Peristaltic pump system. Materials comply with ASTM and other recognized material composition standards. Electrical safety per IEC 60601. Quality systems per ISO 9001/ISO 13485. Pre-sterilized components comply with ISO 10993-5 (cytotoxicity), ANSI/AAMI/ISO 11737-1 (bioburden), and ANSI/AAMI/ISO 11137 (sterilization).

Indications for Use

Indicated for use with Anspach Surgical Motor Systems to provide controlled, cooling irrigation during bone cutting, shaping, and removal procedures, including skull and spine surgery.

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

• Surgical Irrigation System (K030576)

Submission Summary (Full Text)

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K063688

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The Anspach Effort Special 510k Premarket Notification – Surgical Irrigation System: Device Modification

## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter | The Anspach Effort<br>4500 Riverside Drive<br>Palm Beach Gardens, FL 33410 | | JAN 16 2007 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Contact | Jim Banic<br>Senior Regulatory Affairs Specialist<br>The Anspach Effort<br>4500 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Tel. [phone] ext. 515<br>Fax. [phone]<br>Email: [e-mail] | | |
| Date Prepared | January 12, 2007 | | |
| Regulatory Name | Surgical instrument motors and accessories/attachments | | |
| Classification Name | Pump, Infusion | | |
| Product Code | HWE | | |
| Device<br>Classification | Class I<br>General, Restorative and Neurological Devices<br>21 CFR § 878.4820 | | |
| Predicate<br>Devices | Surgical Irrigation System -> K030576 | | |
| Performance Standards | There are no known standards established specifically for<br>an Irrigation System at this time. However, in addition to<br>The 1995 "Draft 510(k) Checklist for Urological Irrigation<br>System and Tubing Set" used in preparation of this Pre-<br>Market Notification. The following standards are<br>applicable to materials and components of the Anspach<br>surgical irrigation system:<br><br>1. ASTM and other similar recognized material<br>composition-related standards<br>2. IEC 60601 and other similar recognized electrical<br>safety standards | | |

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K063688

The Anspach Effort
Special 510k Premarket Notification – Surgical Irrigation System: Device Modification

| 3. | Quality System(s) in addition to US Federal<br>requirements: ISO9001, ISO13485. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. | Bio-safety - Cytotoxicity ISO10993-5 (EN 30993-<br>5) - Pre-sterilized devices only |
| 5. | ANSI/AAMI/ISO 11737-1:1995 Bio burden - Pre-<br>sterilized devices only |
| 6. | ANSI/AAMI/ISO 11137:1994 - Pre-sterilized<br>devices only |
| 7. | AMMI TIR 27: 2001 Alternative (11137) - Pre-<br>sterilized devices only |
| | Note: This list may not represent all applicable standards<br>routinely used or used specifically for surgical<br>irrigation systems. |
| Device Description | The Anspach Irrigation Pump System is a stand-alone<br>pump and pump control system, designed to deliver a<br>constant flow of irrigation fluid by means of a peristaltic<br>pump.<br>The Irrigation Tube, (the subject of this submission), is a<br>fluid delivery device that functions as a component of the<br>irrigation system, to draw fluid from a standard IV bag to a<br>1/16" OD accessory for delivery to the operating<br>site. Tubing size determines the available flow range for<br>the system, while the pump RPM determines the specific<br>flow rate within that range. |
| Indications for Use | Anspach Surgical Irrigation Systems are indicated for use<br>with Anspach Surgical Motor Systems for providing<br>controlled, cooling irrigation during cutting, shaping and<br>removal of bone, including bones of the skull and spine. |
| Technological<br>Characteristics | The Irrigation Tube has the same technological<br>characteristics as the currently available irrigation tube.<br>The only modification is solely in the inner and outer<br>diameter and the length of the tube.<br>The Irrigation Tube is a component of the Surgical<br>Irrigation System which is a delivery system of irrigation<br>fluids available to the surgeon. |
| Conclusion | The irrigation tube, (component to the Surgical Irrigation<br>System), and the subject of this submission, is substantially<br>equivalent to the legally marketed irrigation tube<br>component. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Anspach Effort, Inc. % Mr. Jim Banic Senior Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K063688

Trade/Device Name: Surgical Irrigation System Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: HWE Dated: December 7, 2006 Received: December 20, 2006

JAN 16 2007

Dear Mr. Banic:

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. Jim Banic

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 your

FOR

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KD63684

The Anspach Effort

Special 510k Premarket Notification - Surgical Irrigation System: Device Modification

## Indications for Use

510(k) Number (if known): K063688

Device Name: Surgical Irrigation System

Indications for Use:

Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices Page _ of _

510(k) Number 110203688