(90 days)
Not Found
Not Found
No
The summary describes a mechanical surgical system for cutting and abrading tissue, with no mention of AI or ML components or functions.
No.
The device is used to cut, shave, and abrade bone and tissue during various arthroscopic surgical procedures, rather than treating or curing a disease or condition.
No
The device is described as providing controlled cutting, shaving, and abrading of bone and tissue during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a power unit, handpieces, footswitch, power cord, shaver blades, drill chucks, and sagittal saws. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Karl Storz Powershaver System S2 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures". This describes a surgical tool used directly on a patient's body.
- Device Description: The components listed (power unit, handpieces, footswitch, power cord, shaver blades, drill chucks, sagittal saws) are all consistent with surgical instruments used for mechanical manipulation of tissue and bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the Karl Storz Powershaver System S2 is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.
Product codes
HRX
Device Description
The Powershaver System S2 is comprised of a power unit, handpieces, a footswitch, and a power cord. Other accessories include shaver blades, drill chucks, and sagittal saws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Renate A. MacLaren, Ph.D.
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Arthroscopic Shaver |
| | Trade Name: (optional)
KSEA Powershaver System S2 |
Indication: The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.
Device Description: The Powershaver System S2 is comprised of a power unit, handpieces, a footswitch, and a power cord. Other accessories include shaver blades, drill chucks, and sagittal saws.
Substantial Equivalence: The KSEA Powershaver System S2 is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the KSEA Powershaver System S2 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
ed: Benatefl. Macfar
Signed:
Renate A. MacLaren, Ph.D Senior Regulatory Affairs Specialist
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 the department's symbol, which consists of three stylized human profiles facing to the right. The profiles are arranged in a cascading manner, with each one slightly overlapping the one below it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
APR 0 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist Karl-Storz Endoscopy-America, Inc. 600 Corporate Pointe Drive Culver City, California 90230
Re: K030009
Trade/Device Name: KSEA Powershaver System S2 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: December 30, 2002 Received: January 2, 2003
Dear Dr. MacLaren:
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 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.
2
Page 2 - Renate A. MacLaren, Ph.D.
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 Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): Not yet assigned
KO30009
Device Name: KSEA Powershaver System S2
Indication for Use: The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.
(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 Devices | |
| 510(k) Number | K030009 |
| Prescription Use: | OR Over-The-Counter Use: |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |