(67 days)
Not Found
Not Found
No
The device description focuses on mechanical motion conversion and does not mention any computational or learning capabilities.
No
The device is described as a mechanical attachment that converts rotary motion to oscillating motion to drive a cutting bit, intended for cutting and removal of tissue or bone during surgery. It is a surgical tool, not a device that directly treats a disease or condition therapeutically.
No
Explanation: The device is described as an accessory for cutting and removing tissue/bone during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "mechanical attachment" that converts rotary motion to oscillating motion, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the cutting and removal of soft and hard tissue or bone during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description explains its mechanical function in converting motion to drive a cutting bit. This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Power Attachment for cutting blades / rasps is indicated for use with the XPS Straight Shot Microdebrider during surgical procedures to operate these various accessories to cut hard and soft tissue or bone in orthopedic and otorhinolaryngology and head and neck surgery. These include open spinal surgeries and small and large joint arthroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
77ERL, 79GEY
Device Description
The XPS Power Attachment is a mechanical attachment to the collet drive of the XPS Straight Shot handpiece that converts rotary motion to oscillating motion (forward and backward) to drive the cutting bit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Not Found
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
Revised October 1, 1998
510(k) Summary
1.0 Date Prepared
August 28, 1998
2.0 Submitter (Contact)
Debra B. Cortner Xomed Surgical Products Jacksonville, FL (904) 279-7586
3.0 Device Name
Proprietary Name: Xomed FeatherTouch XPS Power Rasp Attachment,
Drill attachment, oscillating attachment Common Name(s):
ENT surgical drill and Surgical instrument motor accessories Classification Name:
Device Classification 4.0
Procode 77ERL Class II ; 21 CFR 874.4250 Tier 1 ENT Drill Surgical Motors and Accessories Procode 79GEY Class I ; 21 CFR 878.4820 Tier 1 878.4820 is now exempt from 510(k) notification.
Note: Bur rasp /blade tips to be used with the Power Rasp Attachment are exempted from notification by 21 CFR 874.4140 Ear, Nose and Throat Bur. Surgical motors and accessories are exempt from 510(k) under 21 CFR 878.4820.
5.0 Device Description
The XPS Power Attachment is a mechanical attachment to the collet drive of the XPS Straight Shot handpiece that converts rotary motion to oscillating motion (forward and backward) to drive the cutting bit.
6.0 Intended Use
The Power Rasp is intended for use as an accessory to the XPS Straight Shot handpiece The Xomed XPS StraightShot Microdebrider System is intended for the cutting and removal of soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery. It is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is needed. These include open spinal surgeries and small and large joint arthroscopic procedures.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human figures in profile, with their heads overlapping and facing to the right. The figures are connected by a flowing line that forms the shape of a wave or ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Ms. Debra B. Cortner Senior Regulatory Affairs Specialist Xomed, Inc. 6743 Southpoint Dr. North Jacksonville, Florida 32216
Re: K983025 Trade Name: Xomed FeatherTouch XPS Power Rasp Attachment Regulatory Class: II Product Code: HRX Dated: August 28, 1998 Received: August 31, 1998
Dear Ms. Cortner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 - Ms. Debra B. Cortner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number K983025: Device Name: FeatherTouch Power Rasp Attachment Indications for Use:
The Power Attachment for cutting blades / rasps is indicated for use with the XPS Straight Shot Microdebrider during surgical procedures to operate these various accessories to cut hard and soft tissue or bone in orthopedic and otorhinolaryngology and head and neck surgery. These include open spinal surgeries and small and large joint arthroscopic procedures.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Or
Over-the-Counter Use _
(Optional Format 1-2-96)
Ascoeff
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L983025