(120 days)
Not Found
No
The device description lists mechanical components and the intended use is for physical access and preparation. There is no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The device provides minimally invasive access for surgical procedures but does not inherently provide therapy itself. It assists in treatments like lumbar discectomy or spinal fusion, which are therapeutic, but the device's function is access and preparation.
No
This device is described as an access and preparation tool for minimally invasive spinal procedures, not for diagnosing conditions. Its components are for surgical manipulation, not for generating or interpreting diagnostic information.
No
The device description lists multiple physical components (Guide Pin Introducer, Guide Pins, Dilators, etc.) which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is used for minimally invasive access to the anterior portion of the lower spine and for assisting in surgical procedures like discectomy and interbody fusion. It is a surgical tool used on the body, not a test performed on samples from the body.
- Components: The listed components are all surgical instruments (guide pins, dilators, drills, cutters, etc.), not reagents, test kits, or analytical equipment typically associated with IVDs.
Therefore, based on the provided information, the TranS1 Trans-Sacral Spinal Access and Preparation Device is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-S1 interbody fusion.
Product codes
HRX
Device Description
The Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior lower spine and consists of the following components: - Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior portion of the lower spine, lumbar disc, L5-S1
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)
AxiaMed, Inc., Trans-Sacral Spinal Access Device, Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit, Argus Medical Company Laparoscopic Discectomy Instrument System, Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter, Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter, Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System, United States Surgical, Auto Suture Spinal Elevator, Harrington Spinal Elevator, Karlin Technology, Inc., Cobb Spinal Elevator.
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
JAN 1 5 2004
032891 1 1/2
510(k) Summary of Safety and Effectiveness
In Accordance with CFR 807.92 (April 26, 1992), the following information is submitted:
- TranSl, Inc. 1. Name: 1800 Sir Tyler Drive Address: Suite 101 Wilmington, NC 28405
Phone; 910 509-3100 Fax: 910 509-3101
W. Allen Putnam Contact: Date of Summary Preparation: January 12, 2004
- Name of Device: Trans 1 Trans-Sacral Spinal Access and Preparation Device 2. Generic Name: Rigid Endoscope and Instrument Set
-
- Predicate Devices:
AxiaMed. Inc., Trans-Sacral Spinal Access Device
Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit
Argus Medical Company Laparoscopic Discectomy Instrument System
Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter
Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter
Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System
United States Surgical, Auto Suture Spinal Elevator
Harrington Spinal Elevator
Karlin Technology, Inc., Cobb Spinal Elevator.
- Device Description: 4.
The Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior lower spine and consists of the following components:
1
- Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool
- Indication for use: રું .
The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny or for assistance in the performance of L5-S1 interbody fusion.
- Technological Characteristics of the Device: 6.
The TranS1 Trans-Sacral Spinal Access and Preparation Device is designed to gain a minimally invasive access tract to the anterior region of the lower spine and assist in the diagnosis and treatment of the area. This would enable procedures such as biopsy, lumbar fusion, vertebroplasty, etc. The access devices are of such length that access up to L5 is possible.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized graphic of three wavy lines, which may represent the flow of information or services.
JAN 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TranS1, Inc. c/o Mr. W. Allen Putnam RCQ Strategies 6285 Chaska Road Excelsior, Minnesota 55331
Re: K032891
Trade/Device Name: TranS1 Trans-Sacral Spinal Access and Preparation Kit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: December 15, 2003 Received: December 16, 2003
Dear Mr. Putnam:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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). and Cosmeter For (110) the the device, subject to the general controls provisions of the Act. The r ou may more over sections 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 may be subject to such addressar enulations, 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 I least of advised that I Dr is issualso over device complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of any I coleral stututes and regulations, including, but not limited to: registration and listing (21 Comply with an the Act STequirements, assisted on the of manufacturing practice requirements as set CI N Fart 607), additig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. W. Allen Putnam
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to organization of substantial equivalence of your device to a legally prematics notification: "The Province and thus, pour 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 If you desire specific advision at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Companies as the transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K032891
TranS1 Trans Sacral Spinal Access and Preparation Kit
Indications For Use:
Device Name:
The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of LS-S1 interbody fusion.
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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Sion Sign-Off) Tivision of General, Restorative Ad Neurologi
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