(70 days)
No
The device description and performance studies focus on the reprocessing of mechanical arthroscopic accessories and their functional equivalence to predicate devices, with no mention of AI or ML.
No.
The device is used for cutting and resecting tissue during orthopedic joint surgery, which is an interventional procedure, not a therapeutic one. It facilitates the removal of tissue rather than directly treating a condition therapeutically.
No
Explanation: The device is described as an arthroscopic accessory used for resecting tissue in orthopedic joint surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes physical hardware components (burs, blades, housing, rod, hand piece) and their function in orthopedic surgery, indicating it is a hardware device, not software-only.
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 "powered arthroscopic accessories intended for use in orthopedic joint surgery." This describes a surgical tool used directly on a patient during a procedure.
- Device Description: The description details a mechanical device with cutting tips used to resect tissue within a joint. This is a surgical instrument, not a device used to examine specimens from the body in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
MEDISISS Reprocessed Shavers and Burs are powered arthroscopic accessories intended for use in orthopedic joint surgery.
Product codes
HRX
Device Description
Arthroscopic devices reprocessed by MEDISISS include burs and blades at the end of a long rod that rotates within a hollow stainless steel housing. The housing has an opening on one side of the distal end, allowing the cutting tip to resect tissue while protecting adjacent material with the housing on the opposite side of the bur or blade. This system attaches to a motorized hand piece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site. Devices are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic joint
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
The functional characteristics of the subject devices have been evaluated and found to be equivalent to the predicate devices. The patient contacting materials are either identical to the materials of the predicate devices, or have been fully evaluated for biocompatibility and functionality.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the word "MEDISISS" in a bold, sans-serif font. To the left of the word, there is a graphic of lines radiating outward, resembling a sun or starburst. The letters are all capitalized and evenly spaced. There is a trademark symbol to the right of the word.
510(k) Notification: MEDISISS ·Reprocessed Arthroscopic Shavers and Burs
| Section 5: 510(K) Summary | K113028 | DEC 20 20 |
|---|---|---|
| Submitter/ | ||
| Owner | MEDISISS | |
| 2747 SW 6th St. | ||
| Redmond, OR 97756 | ||
| Contact Name | Joyce Elkins | |
| Director of Quality Assurance and Regulatory Affairs | ||
| P: 541-923-3310 | ||
| F: 541-923-3375 | ||
| E: JElkins@MEDISISS.com | ||
| Date Prepared | October 7, 2011 | |
| Device Names | Proprietary Name: MEDISISS Reprocessed Arthroscopic Shavers and | |
| Burs | ||
| Common Name: Arthroscope and Accessories | ||
| Classification | Arthroscope, Class II, 21 CFR 888.1100, product code HRX | |
| Predicate | ||
| Devices | K940075 Arthrex Shaver Blade Set | |
| K012536 SterilMed Reprocessed Powered Arthroscopic Accessories | ||
| K012667 Reprocessed Arthroscopic Shapers | ||
| Device | ||
| Description | Arthroscopic devices reprocessed by MEDISISS include burs and blades | |
| at the end of a long rod that rotates within a hollow stainless steel housing. | ||
| The housing has an opening on one side of the distal end, allowing the | ||
| cutting tip to resect tissue while protecting adjacent material with the | ||
| housing on the opposite side of the bur or blade. This system attaches to a | ||
| motorized hand piece that drives the internal bur or blade inside the outer | ||
| housing and provides suction to pull the cut tissue away from the surgical | ||
| site. Devices are provided sterile. | ||
| Intended Use | MEDISISS Reprocessed Shavers and Burs are powered arthroscopic | |
| accessories intended for use in orthopedic joint surgery. | ||
| Technological | ||
| Characteristics | The technological characteristics of the subject devices are substantially | |
| equivalent to the predicate devices listed in this submission. The subject | ||
| devices have the same functionality and very similar indications as the | ||
| predicate devices. | ||
| Performance | ||
| Testing | The functional characteristics of the subject devices have been evaluated | |
| and found to be equivalent to the predicate devices. The patient contacting | ||
| materials are either identical to the materials of the predicate devices, or | ||
| have been fully evaluated for biocompatibility and functionality. | ||
| Conclusion | Based on comparison of the indications for use, technological | |
| characteristics, and performance data to the predicate devices, MEDISISS | ||
| Reprocessed Arthroscopic Shavers and Burs have been shown to be | ||
| substantially equivalent to the predicate devices. |
1
Image /page/1/Picture/0 description: The image shows the word "MEDISISS" in a bold, sans-serif font. To the left of the word, there is a graphic that resembles a sun or a starburst, with several short lines radiating outward from a central point. The letters are all capitalized and evenly spaced, and there is a small superscript symbol after the last "S" in the word.
。…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medisiss % Ms. Joyce Elkins Director of Quality Assurance and Regulatory Affairs 2747 SW 6th Street Richmond, Oregon 97756
DEC 2 0 2011
Re: K113028
Trade/Device Name: Medisiss Reprocessed Arthroscopic Shavers and Burs Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 22, 2011 Received: December 02, 2011
Dear Ms. Elkins:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Ms. Joyce Elkins
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "MEDISISS" in bold, black letters. To the left of the word, there is a graphic of lines radiating outward from a vertical line, resembling a sunburst. A small "tm" symbol is located to the upper right of the word.
510(k) Notification: MEDISISS Reprocessed Arthroscopic Shavers and Burs
All Information on This Page is Confidential
Section 4: Indications for Use
510(k) Number: TBD KI | 3028
Device Name: MEDISISS Reprocessed Arthroscopic Shavers and Burs
Indications For Use:
MEDISISS Reprocessed Shavers and Burs are powered arthroscopic accessories intended for use in orthopedic joint surgery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R.P. Dale for nxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113028