(136 days)
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 spinal and small and large joint arthroscopic procedures.
The XPS System remains essentially the same as originally described in K963246. There is a Power Control Unit, a footswitch, reusable handpieces and various interchangeable, disposable burs and blades. The system can operate one or two handpieces (one at a time) with suction and irrigation, depending on the handpiece. Xomed now proposes to market the XPS System for the same intended use in orthopedic surgery, including spinal and small and large joint procedures. In order to best meet the needs of the orthopedic surgeons, we have added to the original system, a larger handpiece and additional blades and burs. Other than the larger motor with additional speed and torque, the principle of operation and Power Control Unit remain essentially the same as described in K963246.
This 510(k) submission (K973499) for the XPS StraightShot Microdebrider System describes the device and its intended use, but does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.
The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically focuses on comparing the new device's design, materials, and intended use to existing devices, rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, for your request, I can only provide the following based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The 510(k) summary describes the device and its intended use, and compares it to predicate devices, but does not specify performance acceptance criteria or report on device performance against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document. No performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not available in the provided document. No performance study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document. No performance study data is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not available in the provided document. The device is an electrical surgical shaver/debrider, not an AI-assisted diagnostic tool, so an MRMC study or AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document. No performance study data is presented.
8. The sample size for the training set:
This information is not available in the provided document. No performance study data is presented.
9. How the ground truth for the training set was established:
This information is not available in the provided document. No performance study data is presented.
In summary: The provided 510(k) document focuses on establishing substantial equivalence to predicate devices for the purpose of market clearance. It does not include the detailed performance study data, acceptance criteria, or ground truth establishment requested, as these are typically part of a different type of regulatory submission (e.g., PMA) or internal validation testing. The substantial equivalence argument relies on the safety and effectiveness of the predicate devices.
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JAN 30 1998
K973499
510(k) Summary
- 1.0 Date Prepared September 15, 1997
- 2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
| Proprietary Name: | XPS StraightShot Microdebrider System or TreBayShaver System (The proposed product tradename hasnot been finalized and may be changed at a later date) |
|---|---|
| Common Name(s): | Electrical surgical shavers, electrical debriders, drillhandpieces and cutting blades and burs |
| Classification Name: | Surgical instrument, AC powered motors andaccessories / attachments or Arthroscopes andaccessories |
| Device Classification |
5.0
Surgical instrument, AC powered motors and accessories / attachments Class II : 21 CFR 878.4820 Tier 1 Procode 87HWE
Arthroscopes and accessories
Class II ; 21CFR 888.1100 Tier 2 Procode 87HRX
6.0 Device Description
The XPS System remains essentially the same as originally described in K963246. There is a Power Control Unit, a footswitch, reusable handpieces and various interchangeable, disposable burs and blades. The system can operate one or two handpieces (one at a time) with suction and irrigation, depending on the handpiece. Xomed now proposes to market the XPS System for the same intended use in orthopedic surgery, including spinal and small and large joint procedures. In order to best meet the needs of the orthopedic surgeons, we have added to the original system, a larger handpiece and additional blades and burs. Other than the larger motor with additional speed and torque, the principle of operation and Power Control Unit remain essentially the same as described in K963246.
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7.0 Intended Use
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. Orthopedic use is now added to the original intended use for otorhinolaryngology and head and neck 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 spinal and small and large joint arthroscopic procedures.
8.0 Substantial Equivalence
All of the predicate devices (Linvatec Apex, Stryker SE5, S&N Dyonics PS3500EP, S&N Dyonics Arthroscopic MicroDiscectomy (AMD) System, Sofamor Danek Tissue Resecting System) have similar designs with equivalent characteristics. Most importantly all of the predicate devices are marketed for arthroscopic orthopedic uses. Information on labeling of the predicate devices was included.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol in black, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 1998
Mr. David Timlin Manager, Regulatory Affairs Xomed, Incorporated 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980
K973499 Re:
Trade Name: XPS StraightShot Microdebrider System or TreBay Shaver System Regulatory Class: II Product Code: HRX Dated: December 1, 1997 Received: December 2, 1997 ..
Dear Mr. Timlin:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.
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Page 2 - Mr. Timlin
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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
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K973499 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: XPS StraightShot Microdebrider System
Indications for Use:
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 spinal 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)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973499
Or Over-the-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
revised 3/97
§ 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.