(83 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components for tissue removal, with no mention of AI or ML technologies.
Yes
The device is intended to resect damaged or diseased nucleus pulposus material, which is a therapeutic intervention aimed at treating a medical condition.
No
This device is a surgical tool designed to remove damaged tissue from the lumbar disc space. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is comprised of a disposable, sterile handheld nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal, all of which are hardware components.
Based on the provided information, the XTEND-ST Nucleus Removal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "soft tissue removal device" with a cutting mechanism, suction, and electronic control unit. This is consistent with a surgical instrument used for tissue removal.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The XTEND-ST system operates within the patient's body to remove tissue.
Therefore, the XTEND-ST Nucleus Removal System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy.
The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar disc space
Indicated Patient Age Range
adult
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)
The biological safety of the XTEND-ST cutting device was achieved through the selection of materials that demonstrated appropriate levels of biocompatibility.
Electrical testing was performed on the XTEND-ST Nucleus Removal System per IEC 60601-1 to demonstrate electrical safety, and the result showed the system met the test limits as described for safety testing and conforms to the immunity and emissions requirements for electromagnetic compatibility.
Human factor analysis was conducted and concluded that the XTEND-ST Nucleus Removal System presented acceptable human factors features in both the functioning of the device and usage of the labeling.
Bench testing and cadaver testing were conducted to ensure the performance and safety of the XTEND-ST Nucleus Removal System and to demonstrate substantial equivalent to other commercially cleared tissue removal devices available for sale in the USA.
No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the XTEND-ST System is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 3 0 2009
510(k) Summary (per 21 CFR 807.87(h))
| Common/Usual Name: | Arthroscopic Accessory: Articulating and Extendible
Shaver |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Product Trade Name: | XTEND-ST™ Nucleus Removal System |
| Classification Name: | Arthroscope and Accessory
Class II per 21 CFR § 888.1100
Product Code HRX |
| . Predicate Device: | Endius, Inc. FlexTip Blade, K022578
Clarus Medical, LLC. Nucleotome Probe Set,
K040919
HydroCision, Inc. Arthrojet System, K041233 |
| Manufacturer: | CoreSpine Technologies, LLC
5909 Baker Road, Suite 550
Minneapolis, MN 55345 |
| Contact: | Britt K. Norton
Founder and Chief Operating Officer |
| Date Prepared: | January 30, 2009 |
Device Description:
The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy.
The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.
Indications for Use:
The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.
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Comparison of technological characteristics:
Substantial equivalence of the XTEND-ST Nucleus Removal System with the predicate devices is based on similar intended use/indications for use, design, function and materials of construction. The XTEND-ST Nucleus Removal System and the predicate devices are all intended to remove soft tissue during surgery. However the XTEND ST cutter tip extends along its axis, whereas the predicate devices do not. Verification and validation studies performed on the XTEND-ST Nucleus Removal System demonstrated that this difference does not negatively affect the safety and performance of the device when used as intended.
Summary of Non-Clinical Testing:
The biological safety of the XTEND-ST cutting device was achieved through the selection of materials that demonstrated appropriate levels of biocompatibility.
Electrical testing was performed on the XTEND-ST Nucleus Removal System per IEC 60601-1 to demonstrate electrical safety, and the result showed the system met the test limits as described for safety testing and conforms to the immunity and emissions requirements for electromagnetic compatibility.
Human factor analysis was conducted and concluded that the XTEND-ST Nucleus Removal System presented acceptable human factors features in both the functioning of the device and usage of the labeling.
Bench testing and cadaver testing were conducted to ensure the performance and safety of the XTEND-ST Nucleus Removal System and to demonstrate substantial equivalent to other commercially cleared tissue removal devices available for sale in the USA.
No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the XTEND-ST System is safe and effective for its intended use.
Conclusion:
The XTEND-ST Nucleus Removal System has similar intended use, material biosafety profile, and technical characteristics as the predicate devices. Non-clinical testing was conducted to verify the safety and performance of the XTEND-ST Nucleus Removal System and to ensure the device functions as intended and meets design specifications. As a result, the XTEND-ST Nucleus Removal System has been demonstrated to be substantially equivalent to the predicate devices and effective for its intended use.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus, a symbol of medicine, in its talons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2009
Re: K090303
CoreSpine Technologies, LLC
% Mr. Britt K. Norton 5909 Baker Road, Suite 550 Minneapolis, Minnesota 55345
Trade/Device Name: XTEND-ST™ Nucleus Removal System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: April 13, 2009 Received: April 14, 2009
Dear Mr. Britt:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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
3
Page 2 - Mr. Britt K. Norton
premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Mark A. Milliman
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(090303
Current 510(k) Number: __
Device Name:
XTEND-ST™ Nucleus Removal System
Indications for Use:
The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.
Prescription Use ✔ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number 0000000
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