REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES

K070034 · Ascent Healthcare Solutions · NQG · Aug 17, 2007 · Cardiovascular

Device Facts

• Record ID: K070034
• Device Name: REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
• Applicant: Ascent Healthcare Solutions
• Product Code: NQG · Cardiovascular
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.

Device Story

Reprocessed cardiac stabilization and positioning devices; used in minimally invasive cardiovascular surgery (sternotomy approach) on non-arrested hearts. Components include tissue stabilizers, heart positioners, and sternum retractor blades. Device provides thoracic access, mounts for stabilizers/positioners, and facilitates pericardial suture placement. Tissue stabilizer minimizes beating heart motion; heart positioner uses vacuum suction for positioning. Used in OR by surgeons. Reprocessing involves cleaning, decontamination, and functional testing to ensure performance equivalent to original devices.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, and functional testing of components.

Technological Characteristics

Mechanical cardiovascular surgical instruments. Components: tissue stabilizer, heart positioner, sternum retractor blades. Materials and design identical to original predicate devices. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients undergoing minimally invasive cardiovascular surgery via sternotomy on a non-arrested heart. Used for thoracic access, heart stabilization, and positioning.

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

• Vacuum Assist Stabilizer (K992833)
• CTS Heart-Lift Balloon Positioner (K982419)

Submission Summary (Full Text)

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K070034

.

2007

# SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | AUG 17 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Contact: | Katie Bray<br>RA Specialist/Biomedical Engineer<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | December 29, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Cardiac Stabilization and<br>Positioning Devices | |
| | Classification Name: Cardiovascular surgical instruments | |
| Predicate Device | 510(k) Title<br>K992833 Vacuum Assist Stabilizer<br>K982419 CTS Heart-Lift Balloon Positioner | Manufacturer<br>CardioThoracic Systems (Guidant)<br>CardioThoracic Systems (Guidant) |
| Note: These are class I devices that do not require a 510(k) for original (brand new) devices. Therefore, the predicate device may not have a filed 510(k) from the original manufacturer. | | |
| Device description: | Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades. | |
| Indications for Use: | Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the | |
| CONFIDENTIAL | Ascent Healthcare Solutions | Page 11 |

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predicate devices. The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Ascent Healthcare Solutions's reprocessing of Cardiac Stabilization and Positioning Devices includes removal of adherent visible soil and decontamination. Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations.

Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Cardiac Stabilization and Positioning Devices. This included the following tests:

- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .

Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended.

Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Cardiac Stabilization and Positioning Devices) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2007

Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044

Re: K070034

Reprocessed Guidant (CTS) Cardiac Stabilization and Positioning Devices Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I non-exempt Product Code: NQG Dated: July 20, 2007 Received: July 23, 2007

Dear Ms. Bray:

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 - Ms. Katie Bray

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

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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| ProCode | Family | Model |
|---------|-------------------------------------------------|------------------------------------------------------------------------|
| NQQ | Guidant Heart<br>Stabilizers and<br>Positioners | Ultima Std Foot Stabilizer<br>(OM-2001) |
| | | Ultima Mechanical<br>Stabilizer with Std Blades<br>(OM-2001S) |
| | | Ultima Mechanical<br>Stabilizer Left Offset w/Std<br>Blades (OM-2003S) |
| | | Acrobat Mechanical<br>Stabilizer w/Std Blades<br>(OM-6000S) |
| | | Acrobat SUV Vacuum<br>Stabilizer (OM-9000) |
| | | Acrobat V Vacuum<br>Stabilizer (OM-9100) |
| | | Acrobat SUV Vacuum<br>Stabilizer w/Std Blades and<br>Tubing (OM-9000S) |
| | | Xpose 3 Access Device<br>(XP-3000) |
| | | Xpose 4 Access Device<br>(XP-4000) |
| | | AccessRail Standard Blade<br>Platform (SB-1000) |

:

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### SECTION 4: INDICATIONS FOR USE STATEMENT

## 510(k) Number (if known): 《○フ○○ 34

Device Name: Reprocessed Guidant Cardiac Stabilization and Positioning Devices

#### Indications For Use:

Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.

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 IF NEEDED)

| CONFIDENTIAL | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------|--------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Cardiovascular Devices |
| | 510(k) Ascent Healthcare Solutions |
| | Repressed Dantoic Stabilization Devices |
| | Traditional 510(k) |
| | 76054 |
| | Page 10 |