(128 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device is described as an instrument for shaving, cutting, and abrading bone and tissue during surgical procedures, which are mechanical actions rather than a therapeutic effect on a medical condition.
No
The REMA Shaver Blades are described as intended for "shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures." This indicates an interventional or surgical purpose, not a diagnostic one. No diagnostic functions like detecting, monitoring, or identifying diseases are mentioned.
No
The device description explicitly states it consists of physical components made of stainless steel and PPSU, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The description details the physical components of a surgical shaver blade, designed for mechanical action on tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention.
N/A
Intended Use / Indications for Use
The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.
Product codes
HRX
Device Description
The REMA Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector can consist of stainless steel or Polyphenylsulfone (PPSU). The components are designed and intended to be operated exclusively as a unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and tissue (during arthroscopic surgical procedures)
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)
K023777, K953695, K955914, K901735, K963332, K943985, K990524, K041824, K030009
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.
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Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
for
REMA Shaver Blades
February 20th, 2006
1. Submitter Information:
- a. Manufacturer/ Applicant:
| Manufacturer/ Applicant: | MAY 3 1 2006 | |
|---|---|---|
| Name: | REMA Medizintechnik GmbH | |
| Address: | In Breiten 10 | |
| D-78589 Duerbheim- Tuttlingen | ||
| Germany | ||
| Telephone: | 0049 7424-4064 | |
| Fax: | 0049 7424-501590 | |
| E-Mail: | info@rema-surgery.com |
- b. Correspondent:
| Name: | Innovative Endoscopy Components, LLC |
|---|---|
| Address: | 731-733 Shotgun Road |
| Ft. Lauderdale, FL 33326 | |
| Telephone: | (954) 217-8780 |
| Fax: | (954) 217-8781 |
| E-Mail: | info@endoscopy.md |
-
- Device Name:
| Classification Name: | Arthroscope Accessories |
|---|---|
| Classification Number: | 888.1100 Class II |
| Proprietary Name: | REMA Shaver Blades |
3. Predicate Device:
K023777, Arthronet Blackline Shaver Blades K953695, Smith & Nephew Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E9000 System K041824, NeXtra Arthroscopic Shaver K030009, Karl Storz Powershaver System S2
1
K060/72
Ray 2 of 2
-
- Description of Device:
The REMA Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector can consist of stainless steel or Polyphenylsulfone (PPSU). The components are designed and intended to be operated exclusively as a unit.
- Description of Device:
-
- Indication for use:
The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.
- Indication for use:
-
- Description of safety and substantial equivalence:
The biological safety of the REMA Shaver Blades has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility, which constitute the building blocks of the proposed device.
- Description of safety and substantial equivalence:
These materials are similar or identical to those used for the manufacturing of the predicate devices as well as other brands legally sold in the USA.
-
- Summary:
Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems available for sale in the USA.
- Summary:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of three human figures connected at the shoulders, with their arms raised. The figures are arranged in a triangular formation. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
MAY 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
REMA Medizintechnik GmbH % Innovative Endoscopy Components, LLC Mr. Florian Gruber 731-733 Shotgun Road Ft. Lauderdale, Florida 33326
Re: K060172
Trade/Device Name: REMA Shaver System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 18, 2006 Received: May 22, 2006
Dear Mr. Gruber:
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
3
Page 2 - Mr. Florian Gruber
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 Office of Compliance at (240) 276-0115. 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 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,
Q. Mall
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if knówn): K060172 Device Name: REMA Shaver System Indications For Use:
The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.
AND/OR
Prescription Use
Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use ___________ (Part 21 CFR 801
(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 | K060172 |
| Page 1 of _1 |