(54 days)
No
The device description focuses on mechanical components and modifications to existing technology, with no mention of AI or ML.
Yes
The device is intended for "decompression of the discs in the spine" by aspirating disc material, which directly addresses a medical condition to improve health.
No
The device is described as a "Nucleotome Discectomy Probe" intended for "aspiration of disc material during percutaneous discectomies" and "decompression of the discs in the spine." These are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components such as a Discectomy Probe, guide needle, cannula, dilators, trephine, obturator, measuring scale, skin marking pen, scalpel, and syringe. It also mentions manufacturing materials like stainless steel and plastic.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine." This describes a surgical procedure performed directly on the patient's body to remove tissue.
- Device Description: The device description details surgical instruments like probes, needles, cannulas, dilators, trephines, etc., used for a surgical procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of the Clarus Model 21200 Nucleotome Discectomy Probe does not mention any such function or the analysis of specimens.
Therefore, the Clarus Model 21200 Nucleotome Discectomy Probe is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Clarus Model 21200 Nucleotome Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
Product codes
HRX
Device Description
This 510(k) submission is a modification of the existing Nucleotome devices. previously filed as K844131, K902778, K913145, K914282, K923525, K931109, K942987 and respectively found to be substantially equivalent by the FDA on November 29, 1984; October 30, 1990; December 19, 1991; December 19, 1991; February 9, 1993; March 29, 1994; and October 30, 1995. The modifications represented by this submission, is the addition of thoracic and cervical indications.
The Nucleotome Discectomy Probe is intended to be used for decompression of the discs in the spine (lumbar, thoracic and cervical). The set consists of components necessary, as required for percutaneous surgical techniques. The Model 21200 consists of a Discectomy Probe, a guide needle, a straight cannula, with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. A syringe with a union connector is also included to help maintain the openness of the aspiration tubing.
The Clarus Model 21200 Nucleotome Discectomy Probe, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the devices which have been previously filed with FDA under 510(k) applications K844131, K902778, K913145, K914282, K923525, K931109, K942987 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical and/or thoracic applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device.
As with the previous sets, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected to offer the user a comprehensive set of instruments for disc decompression.
The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar, thoracic, and cervical regions of the 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032473, K844131, K902778, K913145, K914282, K923525, K931109, K942987, K011454, K040424
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
page 1 of 2
Section 4
510(k) Summary
General Information:
Submitted by: Clarus Medical, LLC 1000 Boone Avenue North Minneapolis, MN 55427
| Contact: | Tom Barthel, President | |
|---|---|---|
| Telephone | 763-525-8401 | |
| Facsimile | 763-525-8656 |
| Summary Date | April 5, 2004 |
|---|---|
| Device Name: | 21200 Nucleotome Probe Set |
| Common Name: | Discectomy Probe |
| Classification Name: | Arthroscope and Accessories; 888.1100 |
Predicate Devices:
510(k) Description
Manufacturer
| K032473 Stryker Dekompressor™ Precutaneous Discectomy Probe | Stryker Instruments |
|---|---|
| K844131 Nucleotome | Clarus Medical, LLC* |
| K902778 Nucleotome II Tissue Aspiration/Cutter | Clarus Medical, LLC* |
| K913145 Nucleotome Tissue Aspirator/Cutter | Clarus Medical, LLC* |
| K914282 Nucleotome(r) II (version2) Tissue Aspiration/Cutter | Clarus Medical, LLC* |
| K923525 Nucleotome 3.5 mm Automated Percutaneous Lumbar | Clarus Medical. LLC* |
| K931109 Nucleotome E Kit | Clarus Medical. LLC* |
| K942987 Nucleotome L Kit | Clarus Medical, LLC* |
| K011454 Model 2180 Spinescope Endoscope | Clarus Medical, LLC |
| K040424 Model 1100 Laser Endoscopic Decompression Kit (Pending) | Clarus Medical, LLC |
- See section 11 for letter of transfer.
Intended Use:
The Clarus Model 21200 Nucleotome Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
1
Device Description:
General
This 510(k) submission is a modification of the existing Nucleotome devices. previously filed as K844131, K902778, K913145, K914282, K923525, K931109, K942987 and respectively found to be substantially equivalent by the FDA on November 29, 1984; October 30, 1990; December 19, 1991; December 19, 1991; February 9, 1993; March 29, 1994; and October 30, 1995. The modifications represented by this submission, is the addition of thoracic and cervical indications.
140919
2 of 2
The Nucleotome Discectomy Probe is intended to be used for decompression of the discs in the spine (lumbar, thoracic and cervical). The set consists of components necessary, as required for percutaneous surgical techniques. The Model 21200 consists of a Discectomy Probe, a guide needle, a straight cannula, with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. A syringe with a union connector is also included to help maintain the openness of the aspiration tubing.
Construction
The Clarus Model 21200 Nucleotome Discectomy Probe, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the devices which have been previously filed with FDA under 510(k) applications K844131, K902778, K913145, K914282, K923525, K931109, K942987 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical and/or thoracic applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device.
As with the previous sets, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected to offer the user a comprehensive set of instruments for disc decompression.
The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JN - 1 2004
Mr. Tom Barthel President Clarus Medical, LLC 1000 Boone Avenue North Minneapolis, Minnesota 55427
Re: K040919
Trade/Device Name: Model 21200 Nucleotome Probe Set Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope accessory Regulatory Class: II Product Code: HRX Dated: April 7, 2004 Received: April 8, 2004
Dear Mr. Barthel:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewe 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 for ass battler in the 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 Cosmotion For (110) in the device, subject to the general controls provisions of the Act. The r ou may a visions 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 (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.
3
Page 2 - Mr. Tom Barthel
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo retet 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Echoral micronational 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,
Miriam 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):
K040919 __
Device Name:
Model 21200 Nucleotome Probe Set
Indications for Use:
The Clarus Model 21200 Nucleotome Probe Set is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
XX___ Prescription Use (Part 21 CFR 801 Subpart D)
and the country of the county of the county of
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K040919