(154 days)
Not Found
No
The device description lists only mechanical instruments and there is no mention of AI, ML, image processing, or data sets.
No.
The Transcorp Spinal Access System is an instrument system used for visualization and access to the anterior spine during surgical procedures; it does not directly treat or cure a disease or condition.
No
The description of the device and its intended use focuses on providing surgical access and visualization, not on diagnosing medical conditions. It aids in procedures like disc repair and biopsy, which are treatments or data collection methods, not diagnostic processes themselves.
No
The device description explicitly lists multiple hardware components such as guides, pins, drills, and a mallet, indicating it is a physical instrument system, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Transcorp Spinal Access System clearly state that it is an instrument system used for minimally invasive visualization and access to the anterior spine for surgical procedures. It is a surgical tool used on the body, not a device that analyzes samples from the body.
The device is a surgical instrument system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.
Product codes
HRX
Device Description
The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:
- Left and right orientation guides with 5°-15° of angulation
- Fixation pins, 12-16mm
- Drills, 2-6mm Diameter x 10-18mm Depth
- Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
- Guide Pin Adapter
- Guide Pins
- Quick Disconnect Handle
- Fixation Pin Driver
- Tamp
- Mallet
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine
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)
Cadaver performance testing, functional testing, and comparison to the predicate demonstrated that the Transcorp Spinal Access System can be used in accordance with the Indications for Use. Nonclinical tests demonstrate that the Transcorp Spinal Access System is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
11/3352
510(k) Summary Pursuant to 21 CFR 807.92c
Submitted By:
Andrew Rodenhouse Transcorp, Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-855-5375 Fax: 616-877-4522
Date:
March 29, 2012
Device Information:
Transcorp Spinal Access System Trade Name:
Common Name: Rigid Endoscope and Instrument Set
21 CFR Section 888.1100, Arthroscope Product Classification: Code: HRX
Substantially Equivalent Device:
TranS1 Trans-Sacral Spinal Access and Preparation K032891: Device
Device Description:
The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:
- Left and right orientation guides with 5°-15° of angulation
- Fixation pins, 12-16mm
- Drills, 2-6mm Diameter x 10-18mm Depth
- Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
- Guide Pin Adapter
TransCorp Spinal Access System 510(k) Premarket Notification
Page 5.2
CONFIDENTIAL
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1
- Guide Pins ●
- Quick Disconnect Handle .
- Fixation Pin Driver
- Tamp .
- Mallet .
Intended Use:
The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.
Comparison to Predicate:
The Transcorp Spinal Access System and the predicate device include similar stainless steel instruments used in accessing the spine. The Transcorp Spinal Access Systems shares the same technological characteristics including the types of instruments included, the material, and the function as the predicate system.
Summary of Non Clinical Testing:
Cadaver performance testing, functional testing, and comparison to the predicate demonstrated that the Transcorp Spinal Access System can be used in accordance with the Indications for Use.
Conclusion
Nonclinical tests demonstrate that the Transcorp Spinal Access System is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.
TransCorp Spinal Access System 510(k) Premarket Notification
ನ್ನಾಗಿ
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Transcorp, Inc. % Mr. Andrew Rodenhouse 1000 100th Street SW, Suite F Byron Center, Michigan 49315
Re: K113352
Trade/Device Name: Transcorp Spinal Access System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 30, 2012 Received: March 30, 2012
Dear Mr. Rodenhouse:
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. Please note: CDRH does 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 r reaso be as nove a determination that your device complies with other requirements of the Act that + Drivel 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
APR 1 6 2012
3
Page 2 - Mr. Andrew Rodenhouse
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,
for
Mark N. Mullen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
KI13352
Transcorp Spinal Access System Device Name:
Indications for Use:
The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.
X Prescription Use_ (per CFR 801.109)
Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Dyke for mxm
(Division Sign-Off)
ੀ।
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113352
Page 4.2 CONFIDENTIAL
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TransCorp Spinal Access System 510(k) Premarket Notification