(115 days)
Intended use: In conjunction with a motorized handle (c.g. Power Stick M5/3), the POWER DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill M1, bones can be severed or machined.
Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes:
- . In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications).
- In theracte surgery, e.g. for the removal of hematomas. .
- In sinus surgery, e.g. for the removal of polyps.
- . In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.
The POWER DRIVE ART1 2304 is an enhanced version of our POWER CONTROL 2303, cleared in K030082. The new device has new electronics, new software, additional motor handles, tools and tool holders such as rotary blades/ abraders, saws, sagittal and reciprocal saw attachments, drill chucks, drills and surgical wires.
The POWER DRIVE ART1 2304, consisting of: generator, motor handles, tools (such as rotary blades/ abraders, sagittal and reciprocal saws, drills and surgical wires) and tool holders (such as sagittal and reciprocal saw attachments and drill chucks).
Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition with the new rotary blades and abraders (via RFID technology) and a touch screen for user control.
Multiple use devices are not provided sterile; they must be startlized per their instruction before each use. Single use devices are provided sterife and designed for only one use on or in-a single patient.
Via the integrated CAN-BUS interface, the POWER CONTROL 2304 can be integrated into the R. Wolf RIWO NET SYSTEM with remote control, speech control, and touch-screen monitor.
The provided document is a 510(k) premarket notification for a medical device called "POWER DRIVE ART1 2304 with motor handles, tools and Accessories".
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance metrics) or report device performance in a quantitative manner.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices. The core argument is that:
- The new device has same indications, equivalent design, functions, and materials as previous devices.
- New technological characteristics (electronics, software, additional handles, automatic tool recognition, touch screen) have not diminished safety or effectiveness.
- The device is designed and tested to guarantee safety and effectiveness when used according to instructions.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as none were provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No clinical tests or performance studies with a specific test set are mentioned in the document. The submission states, "No clinical tests performed."
- Data Provenance: Not applicable. As no clinical tests were performed, there is no associated data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Since no clinical tests were performed and no ground truth determination process is described, this information is not available.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical tests or ground truth adjudication methods are mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states "No clinical tests performed." Therefore, no MRMC study was conducted or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This device is a surgical instrument (drive unit for rotary blades/abraders, drills, etc.) and not an AI algorithm. Its performance is intrinsically tied to human operation. Therefore, a standalone performance study in the context of an algorithm is not relevant or reported.
7. Type of Ground Truth Used:
- Not applicable. As no clinical tests were performed, no ground truth was established or used in the context of device performance evaluation as would be seen in an AI/diagnostic device submission. The substantial equivalence argument relies on the inherent safety and effectiveness established for the predicate devices and the manufacturing/design process of the new device.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical medical instrument, not an AI model or software requiring a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8 above).
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Ko 80617
Page 1 of 3
510(k) Su
| Submitter: | Date of Preparation: | ||
|---|---|---|---|
| 25. February 2008 | |||
| Revised: 05 June 2008 | |||
| Company / Institution name: | FDA establishment registration | ||
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | number: | ||
| 14 184 79 | |||
| Division name (if applicable): | Phone number (include area code): | ||
| N.A. | (847) 913 1113 | ||
| Street address: | FAX number (include area code): | ||
| 353 Corporate Woods Parkway | (847) 913-0924 | ||
| City: | State/Province: | Country: | ZIP / Postal Code: |
| Vernon Hills | Illinois | USA | IL 60061 |
| Contact name: | Mr. Ron Haselhorst | ||
| Contact title: | Quality Assurance / Regulatory Affairs Manager |
Product Information:
| Trade name: | Model number: 2304.xxx, |
|---|---|
| POWER DRIVE ART1 2304 with motor handles, tools and Accessories | 8995X.xxx, 8564.xxx, 8996X.xxx,8997X.xxx, 8998X.xxx, 4997X.xxx |
| Common name: | Classification name: |
| Surgical instrument Motor Unit and accessories/attachments for endoscopy | Surgical instrument motors and accessories/attachments. |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K030082 | 1 Power Control 2303 with Power Stick M4 | 1 Richard Wolf |
| 2 K871250 | 2 Intra-articulated arthro power system 2161 | 2 Richard Wolf |
| 3 K970088 | 3 RIWO DRIVE Generator with Footswitch, Motor handles and Single Use Rotary Blades and Abraders | 3 Richard Wolf |
| 4 K984304 | 4 RIWO DRIVE Generator, single use or reusable Rotary Cutters and Burrs | 4 Richard Wolf |
| 5 K984521 | 5 RIWO DRIVE small handle | 5 Richard Wolf |
| 6. K030009 | 6. Powershaver SL | 6. Karl Storz |
| 7. K062849 | 7. DYONICS Power II Shaver System | 7. Smith & Nephew |
1.0 Description
The POWER DRIVE ART1 2304 is an enhanced version of our POWER CONTROL 2303, cleared in K030082. The new device has new electronics, new software, additional motor handles, tools and tool holders such as rotary blades/ abraders, saws, sagittal and reciprocal saw attachments, drill chucks, drills and surgical wires.
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2.0 Intended Use
Page 283
In conjunction with a motorized handle (e.g. Power Stick M5/3), the POWER Intended use: DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill MI, bones can be severed or machined.
Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes:
- . In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications).
- In thoracic surgery, e.g. for the removal of hematomas. .
- In sinus surgery, e.g. for the removal of polyps. ●
- In spinal surgery (arthroscopic microdiskectomy (AMD) for removing . degenerated tissue.
3.0 Technological Characteristics
The POWER DRIVE ART1 2304, consisting of: generator, motor handles, tools (such as rotary blades/ abraders, sagittal and reciprocal saws, drills and surgical wires) and tool holders (such as sagittal and reciprocal saw attachments and drill chucks).
Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition with the new rotary blades and abraders (via RFID technology) and a touch screen for user control.
Multiple use devices are not provided sterile; they must be startlized per their instruction before each use. Single use devices are provided sterife and designed for only one use on or in-a single patient.
Via the integrated CAN-BUS interface, the POWER CONTROL 2304 can be integrated into the R. Wolf RIWO NET SYSTEM with remote control, speech control, and touch-screen monitor.
4.0 Substantial Equivalence
The submitted POWER Drive 2304 generator have same indications, equivalent design, functions and materials as the previous devices sold by Richard Wolf. The new device has new electronics, new software, additional motor handles, tools and tool holders.
Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition for the new rotary blades and abraders. Together with the touch screen control, this increases the user comfort and avoids damage caused by incorrect settings.
The new inner sheaths of the rotary blades and abraders have a DLC (diamond-like carbon) coating to reduce friction. The housing of the new drill is made of anodized Aluminum. .
Submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-cleared devices sold by Richard Wolf, Karl Storz, and Smith & Nephew
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Page 383
5.0 Performance Data No performance standards are known.
- 6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in thick, black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Richard Wolf Medical Instruments Corporation % Mr. Ron Haselhorst Quality Assurance/Regulatory Affairs Manager 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K080617
Trade/Device Name: POWER DRIVE ART1 2304 with motor handles, tools and Accessories Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, HWE, ERL, GEY Dated: June 5, 2008 Received: June 13, 2008
Dear Mr. Haselhorst:
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.
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
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Page 2 - Mr. Ron Haselhorst
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.
This letter will allow you to begin marketing your device as described in your Section 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.
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 premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Mulhearn
Mark N. Melkerson Director 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
510(k) Number (if known):
Device Name: POWER DRIVE ARTI 2304 with motor handles, tools and Accessories
-
Intended use: In conjunction with a motorized handle (c.g. Power Stick M5/3), the POWER DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill M1, bones can be severed or machined.
Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes: -
. In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications).
-
In theracte surgery, e.g. for the removal of hematomas. .
-
� In sinus surgery, e.g. for the removal of polyps.
-
. In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.
Prescription Use > (Part 21CFR 801 Subpart D) AND/OR
Over-The Counter Use (Part 21CFR 801 Subpart C)
(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, and Neurological Devi
510(k) Number K080617
§ 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.