(42 days)
GAD
Not Found
No
The description focuses on mechanical components for surgical retraction and does not mention any AI/ML capabilities or data processing.
No
The device is a retractor system designed to provide surgical access by retracting tissue during minimally invasive cardiothoracic procedures. It does not exert a therapeutic effect on the patient.
No
The device is described as a retractor system used to provide surgical access by retracting tissue. This is a surgical tool, not a device used to diagnose a medical condition.
No
The device description explicitly states it consists of physical components made of chrome-coated stainless steel (retractor rack and blades), indicating it is a hardware device, not software-only.
Based on the provided information, the ThoraTrakTM minimally invasive cardiac surgery (MICS) retractor system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide surgical access by retracting soft and bony tissue during minimally invasive cardiothoracic procedures. This is a mechanical function performed directly on the patient's body.
- Device Description: The device is described as a system of retractor racks and blades made of stainless steel. This is a surgical instrument used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with the body during a surgical procedure in the way a retractor does.
N/A
Intended Use / 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 grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.
Product codes
GAD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall, pleural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ThoraTrak™ MICS Retractor System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
1
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.
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 grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.
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.
2
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
3
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