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 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.

AI/ML Overview

The provided text describes a 510(k) submission for "Reprocessed Cardiac Stabilization and Positioning Devices" (K070034). This submission focuses on demonstrating substantial equivalence to predicate devices for reprocessed medical instruments, rather than a novel AI or diagnostic device. As such, the typical acceptance criteria and study designs relating to AI performance (e.g., sensitivity, specificity, reader studies, ground truth establishment) are not applicable.

Instead, the submission details how the reprocessed device meets performance standards to be considered safe and effective, and equivalent to the original predicate devices.

Here's an analysis of the provided text based on your request, highlighting why some aspects are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for reprocessed devices)	Reported Device Performance
Functional Equivalence	"The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. The mechanism of action...is identical...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." "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations." "Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended."
Material/Biocompatibility	"Biocompatibility" testing was conducted. (Specific acceptance values for biocompatibility are not detailed in this summary).
Reprocessing Effectiveness	"Validation of reprocessing" was conducted, including "removal of adherent visible soil and decontamination." (Specific acceptance values for cleaning and decontamination are not detailed).
Sterility Assurance	"Sterilization Validation" was conducted. (Specific acceptance criteria for sterilization are not detailed).
Packaging Integrity	"Packaging Validation" was conducted. (Specific acceptance criteria for packaging are not detailed).

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for each test (biocompatibility, reprocessing validation, etc.). It states that "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components." This implies testing on multiple reprocessed units.

Test Set Size: Not explicitly stated as a single "test set" in the context of an AI study.
Data Provenance: N/A for this type of device. The "data" here refers to bench and laboratory testing results of the reprocessed devices themselves, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This concept is not applicable here. Ground truth in the context of medical device reprocessing refers to validated standards for cleanliness, sterility, functional integrity, and biocompatibility, not expert interpretation of images or clinical data. No "experts" in the sense of clinical reviewers are mentioned for establishing ground truth on these performance tests.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. The tests described are objective, laboratory-based performance tests with predefined pass/fail criteria based on engineering and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The device in question is a reprocessed surgical instrument.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is an AI-specific concept. The "algorithm" here is the reprocessing procedure, and its performance is assessed via the various validations listed (biocompatibility, sterilization, function, etc.).

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed device is established by:

Validated Standards: For biocompatibility, sterility, and packaging.
Original Device Specifications/Performance: For functional equivalence, ensuring the reprocessed device performs "as originally intended" and identically to the predicate device.
Regulatory Requirements: For decontamination and overall safety/effectiveness.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of reprocessed medical instruments. This term is specific to machine learning and AI algorithms.

9. How the Ground Truth for the Training Set Was Established

N/A, as there is no training set.

Summary

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K070034

2007

SECTION 5: 510(k) SUMMARY

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044	AUG 17
Contact:	Katie BrayRA Specialist/Biomedical Engineer(480) 763-5300 (o)(480) 763-6089 (f)kbray@ascenths.com
Date of preparation:	December 29, 2006
Name of device:	Trade/Proprietary Name: Reprocessed Cardiac Stabilization andPositioning Devices
	Classification Name: Cardiovascular surgical instruments
Predicate Device	510(k) TitleK992833 Vacuum Assist StabilizerK982419 CTS Heart-Lift Balloon Positioner	ManufacturerCardioThoracic Systems (Guidant)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.
Technologicalcharacteristics:	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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 HeartStabilizers andPositioners	Ultima Std Foot Stabilizer(OM-2001)
		Ultima MechanicalStabilizer with Std Blades(OM-2001S)
		Ultima MechanicalStabilizer Left Offset w/StdBlades (OM-2003S)
		Acrobat MechanicalStabilizer w/Std Blades(OM-6000S)
		Acrobat SUV VacuumStabilizer (OM-9000)
		Acrobat V VacuumStabilizer (OM-9100)
		Acrobat SUV VacuumStabilizer w/Std Blades andTubing (OM-9000S)
		Xpose 3 Access Device(XP-3000)
		Xpose 4 Access Device(XP-4000)
		AccessRail Standard BladePlatform (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:

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

Regulation Number and Section

§ 870.4500 Cardiovascular surgical instruments.

(a)
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.(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 the limitations in § 870.9.