The ThoraTrakTM minimally invasive cardiac surgery (MICS) retractor system is intended to provide surgical access for minimally invasive cardiothoracic procedures, including minimally invasive coronary artery bypass grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.

Device Description

The ThoraTrak™ minimally invasive cardiac surgery (MICS) retractor system is designed for use with a minimally invasive thoracotomy, an incision in the chest wall into the pleural space, for procedures that include Coronary Artery Bypass Grafting (CABG) and Left Internal Mammary Artery (LIMA) harvesting. It consists of a retractor rack, 2 sets of LIMA blades, 4 sets of thoracotomy blades, and 2 extended mount blades. The retractor rack and blades are chromecoated stainless steel. They are non-sterile, nonpyrogenic, and reusable.

AI/ML Overview

This document K132645 is a 510(k) summary for a Class I manual surgical instrument (ThoraTrak™ MICS Retractor System). Class I devices generally have the lowest risk and typically do not require extensive clinical studies or performance data to demonstrate substantial equivalence to a predicate device.

The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for devices requiring performance testing (e.g., diagnostic devices, software devices).

Here's why and what can be inferred:

Device Type: The ThoraTrak™ MICS Retractor System is a manual surgical instrument, specifically a retractor. For such devices, the primary considerations for substantial equivalence often revolve around material safety, mechanical integrity, and equivalence in design and intended use to existing predicate devices.
Regulatory Class: It is classified as Class I (21 CFR 878.4800, Product Code: GAD). Class I devices are subject to general controls, which generally focus on aspects like good manufacturing practices, labeling, and adverse event reporting, rather than extensive clinical performance studies.
510(k) Summary Content: The summary focuses on comparing the modified device to a legally marketed predicate device, highlighting similarities in intended use, technological characteristics, operating principle, design features, base materials, and shelf life. This is the typical approach for demonstrating substantial equivalence for Class I devices where fundamental safety and effectiveness are established by the predicate.

Therefore, for this specific device and submission, the following points would apply if we were to try and complete the requested table and information, recognizing that the supplied text does not detail all items:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for Class I Manual Surgical Instruments)	Reported Device Performance (Summary of K132645)
Mechanical Integrity/Durability: Device maintains its structural integrity and functionality during intended use.	Not explicitly stated as a numerical criterion or test result, but implied by "Same operating principle" and "Same base materials" as the predicate device. The device is reusable, suggesting durable materials and construction.
Biocompatibility: Materials are safe for patient contact.	Not explicitly stated as a separate criterion, but implied by "Same base materials" as the predicate device, which would have established biocompatibility. The device is non-sterile and non-pyrogenic.
Dimensional & Design Equivalence: Device dimensions and design features are equivalent to the predicate, allowing for comparable performance.	"Same design features" and "Same technological characteristics" as the predicate device are stated, indicating this criterion is met.
Functional Equivalence: Device performs its intended function (tissue retraction) as effectively as the predicate.	"Same intended use," "Same operating principle," and "Same design features" are stated, implying functional equivalence to the predicate.
No New Safety or Effectiveness Concerns: The modifications do not introduce new risks or reduce effectiveness compared to the predicate.	The conclusion states "the indications for use modification... results in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and overall intended use are unchanged from the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/Not provided. The submission focuses on substantial equivalence based on design and material comparison to a predicate, not on a clinical or performance test set with a sample size as typically understood for diagnostic or interventional devices.
Data Provenance: Not applicable/Not provided. There is no "data" in the sense of patient or test results presented in this 510(k) summary. The comparison is based on device specifications and regulatory assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. There was no "test set" requiring expert-established ground truth for a device like this.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This device is a manual surgical retractor, not an AI-assisted diagnostic or interventional system.

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

Not applicable/Not provided. This device is a manual surgical retractor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. The "ground truth" for this filing is the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its history of use and prior regulatory clearance.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" for a device of this type.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary

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K132645

OCT 0 4 2013

510(k) Summary

Date Prepared: Submitter:

August 21, 2013

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009

Contact Person:

Chelsea L. Pioske Associate Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9838 Fax: 763.367.8360 Email: chelsea.pioske@medtronic.com

Alternate Contact:

Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: 763.514.9839 763.367.8360 Fax: Email: susan.c.fidler@medtronic.com

Device Name and Classification

Trade Name:	ThoraTrak™ MICS Retractor System
Common Name:	Retractor, Manual surgical instrument for general use
Regulation Number:	21 CFR 878.4800
Product Code:	GAD
Product Classification:	Class I

Predicate Devices

Legally Marketed	ThoraTrak™ MICS Retractor System
Class I Retractor System

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Device Description

Indications for Use

Comparison to Predicate Devices

A comparison of the modified product to the currently marketed predicate products indicates the following similarities:

o Same intended use and target market
� Same technological characteristics
� Same operating principle
. Same design features
. Same base materials
. Same shelf life

Conclusion

Medtronic has demonstrated that the indications for use modification made to the ThoraTrak™ minimally invasive cardiac surgery (MICS) retractor system described in this submission results in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and overall intended use are unchanged from the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Dog Administration 10903 New Hampshire Avenue Document Control Center - WO06-Gb09 Silver Spring, MD 20993-0002

October 4, 2013

Medtronic, Incorporated Ms. Chelsca Pioske Associate Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428

Re: K132645

Trade/Device Name: ThoraTrak" MICS Retractor System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: GAD Dated: August 21, 2013 Received: August 23, 2013

Dear Ms. Pioske:

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 reclassitied 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Chelsea Pioske

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -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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K132645

Statement of Indications for Use

510(k) Number (if known):

Device Name: ThoraTrak™ MICS Retractor System

Indications for Use:

The ThoraTrakTM minimally invasive cardiac surgery (MICS) retractor system is intended to provide surgical access for minimally invasive cardiothoracic procedures. including minimally invasive coronary artery bypass graffing (CABG) surgery and LIMA harvest by retraction of soft and bony tissue.

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

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

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

Concurence of CDRH. Office of Device Evaluation (ODE)

Long H. Chen -A

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132645

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.