(80 days)
No
The device description and performance studies indicate a manual surgical instrument with no mention of AI or ML capabilities.
No.
The device is a surgical instrument for cutting and removing tissue, which is a procedural tool rather than a device designed to directly diagnose, cure, mitigate, treat, or prevent disease or affect the structure or any function of the body as a therapeutic agent.
No
The device is described as a surgical instrument for cutting and removing tissue during discectomy procedures, not for diagnosing conditions.
No
The device description clearly outlines a physical, manual surgical instrument with a cutting head, shaft, and handle, designed for mechanical tissue removal. There is no mention of software components.
No, the XTool™ Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- XTool™ Function: The XTool™ Device is a surgical instrument used directly on the patient's body during a spinal discectomy procedure. It is used for cutting and removing tissue in vivo (within the living body).
- Intended Use: The intended use clearly states it's for "spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries." This describes a surgical intervention, not a diagnostic test performed on a specimen.
- Device Description: The description details a manual surgical instrument with a cutting head, shaft, and handle for suction. This is consistent with a surgical tool, not an IVD.
The XTool™ is a surgical device, specifically an orthopedic manual hand-held surgical instrument.
N/A
Intended Use / Indications for Use
The XTool™ Device is indicated for spinal discectomy, procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.
Product codes
HRX, NBH
Device Description
The XTool™ is an orthopedic manual hand held surgical instrument for use in performing discectomy in open and minimally invasive spine procedures. It is composed of an angled cutting head with serrated cutting edges and a distal guard, and a hollow shaft that connects the cutting head to the handle proximal. The handle has a port for connecting to standard hospital wall or pump suction. Two different diameter devices are specified to accommodate the range of disc heights for which a discectomy can be performed, with the smaller diameter for lower height discs, and the larger diameter for larger height disc. Two different tip angles are also specified to facilitate ipsilateral and contralateral disc removal. The finished assembly working length is 22 cm, Tip Angle is 15° or 40° and the cutter head diameter is either 5.2 mm or 6.3 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
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)
Biocompatibility testing demonstrates that the device is in compliance with ISO 10993 for biocompatibility of the product.
Sterilization Validation has demonstrated that the device is in compliance with ISO 11137 standards for product sterility assurance.
Packaging Validation has demonstrated that the device is in compliance with ISO 11607-1.
Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.
Simulated use cadaver testing demonstrated that the device can be used as intended in humans.
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
K/22861
Section 5: 510(k) Summary
DEC 0 7 2012
| Category | Comments |
|---|---|
| Sponsor: | Ouroboros Medical, Inc. |
| 47757 Fremont Blvd., | |
| Fremont, CA 94538 | |
| Correspondent Contact | |
| Information: | Shelley Trimm |
| Consultant, Regulatory Affairs | |
| Ouroboros Medical, Inc. | |
| 47757 Fremont Blvd., | |
| Fremont, CA 94538 | |
| Tel: 510 933-3441 | |
| Fax: (866) 931-5422 | |
| Email:shelleytrimm@sbcglobal.net | |
| Device Common Name: | Arthroscope and Accessories |
| Device Classification & | |
| Code: | Arthroscope: Class II, HRX |
| Arthroscope Accessories: Class I, NBH | |
| Device Classification | |
| Name: | 21 CFR § 888.1100 Arthroscope and |
| Accessories | |
| Device Proprietary Name: | XTool™ MIS DISCECTOMY |
Predicate Device Information:
| Predicate Devices: | Arthrojet/SpineJet | Laparoscopic Disc Removal
System |
|--------------------------------------------|-----------------------------|-------------------------------------|
| Predicate Device
Manufacturers: | HydroCision | Blackstone Medical Inc. |
| K#s | 041233 | 972768 |
| Predicate Device Common
Name: | Arthroscope and Accessories | Arthroscope and Accessories |
| Predicate Device
Classification: | 21 CFR § 888.1100 | 21 CFR § 888.1100 |
| Predicate Device
Classification & Code: | Arthroscope: Class II, HRX | Arthroscope: Class II, HRX |
b. Date Summary Prepared
September 1, 2012
Description of Device C.
The XTool™ is an orthopedic manual hand held surgical instrument for use in performing discectomy in open and minimally invasive spine procedures. It is composed of an angled cutting head with serrated cutting edges and a distal guard, and a hollow shaft that connects the cutting head to the handle proximal. The handle has a port for connecting to standard hospital wall or pump suction. Two different diameter devices are specified to accommodate the range of disc heights for which a discectomy can be performed, with the smaller diameter for lower height discs, and the larger diameter for larger height disc. Two different tip angles are also specified to facilitate ipsilateral and contralateral disc removal. The finished assembly working length is 22 cm, Tip Angle is 15° or 40° and the cutter head diameter is either 5.2 mm or 6.3 mm.
1
Indications for Use
The XTool™ Device is indicated for spinal discectomy, procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.
Comparison to Predicate Device e.
The Ouroboros Medical XTool™ MIS DISCECTOMY Device is substantially equivalent in intended use and technology to the currently marketed predicate devices the HydroCision Arthrojet/SpineJet handpiece (K041233) and the Blackstone Medical Inc. Laparoscopic Disc Removal System (K972768). Both the Application device and the predicate devices provide a means to cut soft tissue, remove cartilage, and aspirate tissue through a stainless steel tube in spinal surgeries. The Arthrojet/SpineJet has a cutting blade () at the tip and a tip orifice that draw tissue in to be aspirated through the collection tube. The XTool™ Device also has a cutting blade at the tip with a tip opening for drawing in tissue to be aspirated through a stainless steel tube. The Blackstone Laparoscopic Disc Removal System also has cutting edges around an opening at the tip that draws tissue in using suction to be aspirated through the stainless steel tube.
f. Summary of Supporting Data
Biocompatibility testing demonstrates that the device is in compliance with ISO 10993 for biocompatibility of the product.
Sterilization Validation has demonstrated that the device is in compliance with ISO 11137 standards for product sterility assurance.
Packaging Validation has demonstrated that the device is in compliance with ISO 11607-1.
Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.
Simulated use cadaver testing demonstrated that the device can be used as intended in humans.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 7, 2012
Ouroboros Medical % Ms. Shelley Trimm Consultant, Regulatory Affairs 47757 Fremont Boulevard Fremont, California 94538
Re: K122861
Trade/Device Name: XTool™ MIS DISCECTOMY Device Regulation Number: 21 CFR 888.1100 · Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 18, 2012 Received: October 19, 2012
Dear Ms. Trimm:
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 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
3
Page 2 -- Ms. Shelley Trimm
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/ReportaProblem/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 vours.
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
510(k) Number (if known): K122861
Device Name: XTool™ MIS DISCECTOMY Device
Indications For Use: The XTool™ Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Page 1 of _ l
Neil R Ogden 2012.12.03 11:56:08 -05'00'
(Division Sign-off) Division of Surgical Devices 510(k) Number