REPROCESSED HEART STABILIZERS AND POSITIONERS

K063844 · Sterilmed, Inc. · NQG · Mar 15, 2007 · Cardiovascular

Device Facts

• Record ID: K063844
• Device Name: REPROCESSED HEART STABILIZERS AND POSITIONERS
• Applicant: Sterilmed, Inc.
• Product Code: NQG · Cardiovascular
• Decision Date: Mar 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery.

Device Story

Reprocessed heart stabilizers and positioners are retractor-based surgical instruments used during cardiovascular procedures. Heart stabilizers consist of two tissue stabilizers attached to an articulating arm, which fastens to a retractor via a mounting clamp. The stabilizers feature suction pods controlled by a stopcock to secure tissue on either side of an anastomosis site. Heart positioners incorporate a silicone suction apparatus, an articulating arm, and a mounting clamp to lift and expose coronary arteries. Devices are used in an OR setting by surgeons. Reprocessing involves cleaning and sterilization of previously used devices to restore them to functional state. The device facilitates surgical access and exposure, potentially improving outcomes in off-pump cardiac procedures.

Clinical Evidence

Bench testing only. Functional testing performed on representative samples to demonstrate appropriate characteristics. Process validation conducted for cleaning, sterilization, and packaging. Manufacturing process includes visual and functional testing of all products.

Technological Characteristics

Retractor-based mechanical instruments. Components include articulating arms, mounting clamps, and suction pods/apparatus. Materials include silicone for suction components. Operation relies on regulated vacuum/suction for tissue stabilization and mechanical articulation for positioning. Sterilization is performed as part of the reprocessing cycle.

Indications for Use

Indicated for use during cardiovascular surgery to stabilize, move, lift, and position the heart. Tissue stabilizers are indicated to stabilize and minimize movement of localized areas of a beating heart during off-pump cardiac surgery. Tissue positioners are indicated to lift and hold the heart in position during cardiac surgery.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Predicate Devices

• Medtronic Octopus Tissue Stabilizer (and positioner) (K964445)

Reference Devices

• Octopus 3.0 Stabilizer
• Octopus 4.0 Stabilizer
• Octopus 4.3 Stabilizer
• Starfish 2 Positioner
• Urchin Positioner

Submission Summary (Full Text)

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**STERILMED, INC.**
Medical Device Reprocessing
Small Equipment & Instrument Repair

For Reprocessed Heart Stabilizers And Positioners

K063844

MAR 1 5 2007

## II. SUMMARY AND CERTIFICATION

## 510(k) Summary A.

| Submitter: | SterilMed, Inc. |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dennis Toussaint<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 888-856-4870<br>Fax: [phone] |

| Date Prepared: | December 22, 2006 | |
|------------------------|-----------------------------------------------|--|
| Trade Name: | Reprocessed Heart Stabilizers and Positioners | |
| Classification Name: | Cardiovascular Surgical Instruments | |
| Classification Number: | Class I, 21 CFR 870.4500 | |
| Product Code: | NQG | |

| Predicate<br>Devices: | The reprocessed heart stabilizers and positioners are substantially equivalent to the<br>Medtronic Octopus Tissue Stabilizer (and positioner) (K964445). The non-<br>reprocessed heart stabilizers and positioners are Class I, 510(k) exempt devices. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers<br>attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to<br>15 mm apart, nominally. The articulating arm fastens to a retractor by use of a<br>mounting clamp. The arm is tightened and loosened by a large knob on the proximal<br>end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc<br>fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With<br>the pods placed on either side of the anastamosis site, suction is applied to stabilize the<br>tissue.. A stopcock provides control of suction. |
| | Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to<br>facilitate access to and enhance exposure of the coronary arteries for coronary artery<br>bypass procedures. The device is retractor-based and incorporates a silicone suction<br>apparatus, an articulating arm and a mounting clamp. The silicone apparatus is<br>attached to the surface of the heart by the application of regulated vacuum. The<br>mounting clamp has been designed to be compatible with most adult median<br>sternotomy retractors. |
| Intended Use: | Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift,<br>and position the heart during cardiovascular surgery. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed heart stabilizers and positioners underwent<br>functional testing to demonstrate appropriate functional characteristics. Process<br>validation testing was done to validate the cleaning and sterilization procedures as well<br>as device packaging. In addition, the manufacturing process includes visual and<br>functional testing of all products produced. |

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For Reprocessed Heart Stabilizers And Positioners

| <b>Conclusion:</b> | The reprocessed heart stabilizers and positioners are substantially equivalent to the Octopus Tissue Stabilizer (and Positioner) (K964445) manufactured by Medtronic. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

. . . .

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MAR 1 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed Inc. c/o Mr. Dennis Toussaint Director of Regulatory Affairs 11400 73td Avenue North Maple Grove, MN 55369

Re: K063844

> Octopus 3.0, 4.0, and 4.3 Stabilizers, Starfish 2 Positioner, and Urchin Positioner Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I Product Code: NOG Dated: February 23, 2007 Received: February 26, 2007

Dear Mr. Toussaint:

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.

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Page 2 - Mr. Dennis Toussaint

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. 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,

ina R. Luchtner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K063844

Device Name: Reprocessed Heart Stabilizers and Positioners

Indications For Use:

Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Jahner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) number K063844

Page 1 of 1

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| ProCode | Family | Model |
|---------|---------------------------------------------------|------------------------|
| NQG | Medtronic Heart<br>Stabilizers and<br>Positioners | Octopus 3.0 Stabilizer |
| | | Octopus 4.0 Stabilizer |
| | | Octopus 4.3 Stabilizer |
| | | Starfish 2 Positioner |
| | | Urchin Positioner |