(302 days)
Not Found
No
The description details a manual surgical instrument with no mention of software, algorithms, or any technology that would suggest AI/ML.
No.
The device is described as a surgical instrument used to remove disc material, not to treat a disease or condition.
No
The device is described as an instrument for removing fibrous disc material, not for diagnosis. Its function is to assist in surgical removal, which is a treatment, not a diagnostic process.
No
The device description explicitly states it is a "single-use manual instrument" with physical components like a handle, shaft, cutting blades, and a blunt tip. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Tiger Discectomy Device Function: The description clearly states the Tiger Discectomy Device is a manual instrument used during a surgical procedure to remove disc material within the body. It is a surgical tool, not a diagnostic test performed on a specimen.
The intended use and device description confirm its role as a surgical instrument for removing tissue, not for analyzing a sample to diagnose a condition.
N/A
Intended Use / Indications for Use
The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.
Product codes
HTT, HRX
Device Description
The Tiger Discectomy Device is a single-use manual instrument. The components of the device include a "T" handle, a shaft, two cutting blades and blade holder, retaining pins and a blunt tip. Cutting blades are available in 8mm, 10mm and 12mm widths. A cannula is provided for endoscopic applications. The device is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T12 to S1 spinal segments
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)
Disk Whisk Cutting Device (K971342), Trans1 Trans-sacral Spinal Access and Preparation Device (K032891)
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
Kori2iyo
510(k) Summary according to 807.92(c)
| Contact: | Tim Lusby
Amendia, LLC
1155 Allgood Road, Suite 6
Marietta, GA 30062
770-874-0935 | FEB 27 2009 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name: | Tiger Discectomy ® Device | |
| Product Class: | Class II | |
| Classification: | 888.4540 | |
| Product Codes: | HTT | |
| Panel Code: | 87 | |
| Indications for Use: | The Tiger Discectomy Device is indicated for use in endoscopic
and non-endoscopic spinal procedures to assist in the removal of
fibrous disc material between the T12 to S1 spinal segments. | |
| Device Description: | The Tiger Discectomy Device is a single-use manual instrument.
The components of the device include a "T" handle, a shaft, two
cutting blades and blade holder, retaining pins and a blunt tip.
Cutting blades are available in 8mm, 10mm and 12mm widths. A
cannula is provided for endoscopic applications. The device is
provided sterile. | |
| Predicate Device(s): | The predicate device previously cleared by FDA is the
Disk Whisk Cutting Device (K971342) and the Trans1
Trans-sacral Spinal Access and Preparation Device
(K032891). | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2009
Spinal Devices, LLC % Silver Pine Consulting Mr. Richard Jansen 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K081240
Trade/Device Name: Tiger Discectomy Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope . Regulatory Class: II Product Code: HRX Dated: January 9, 2009 Received: January 12, 2009
Dear Mr. Jansen:
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.
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 (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.
2
Page 2 - Mr. Richard Jansen
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) 276-0115. 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 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,
Daniel Kione
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use
510(k) Number K081240
Indications for Use:
The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.
Prescription Use ﮯ (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 OF NEEDED)
Neil RP Ryder formxm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
K081240 510(k) Number_
Concurrence of CDRH, Office of Device Evaluation (ODE)