(158 days)
Not Found
No
The summary describes an electrically powered surgical debridement system with a voice activation feature, but there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The voice activation is compared to a predicate device, suggesting a more traditional control system.
Yes
The device is used for intra-articular debridement to resect tissue and bur bone, which are therapeutic interventions.
No
Explanation: The device description states that the SE5 Arthroscopy and Small Joint Debrider Systems are designed for "intra-articular debridement" and are used "to resect tissue and bur bone." This indicates a therapeutic or surgical function, rather than a diagnostic one.
No
The device description clearly states it is "electrically powered instrumentation" and includes a "control console" and "Shaver Handpiece," indicating it is a hardware device with potential software components, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used for the physical removal and shaping of tissue (morselization, debridement, resection, burring) within joints during surgical procedures. This is a direct intervention on the body, not a test performed on samples taken from the body.
- Device Description: The description clearly states it's "electrically powered instrumentation specifically designed for intra-articular debridement." This describes a surgical tool.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro 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 instrument used for treatment.
N/A
Intended Use / Indications for Use
The SE5 Arthroscopy System is intended to be used by surgeons in orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint. It will be used to resect tissue and bur bone.
Indications for use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
Product codes
GCJ
Device Description
The SE5 Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically designed for intra-articular debridement. A common control console powers the SE5 Shaver Handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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11. Premarket Notification 510(k) Safety and Effectiveness Summary
Stryker SE5 Arthroscopy System with HERMES OR Control Center System 510(k) Summary
Stryker Endoscopy is submitting the following safety and effectiveness summary.
- l) Submitter Information
Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 (408) 567-2179 Contact: Salmaan Hameed Prepared December 18, 1997
- Name of Device:
Proprietary Name: SE5 Arthroscopy System with HERMES Voice Control™ Common Name is SE5 Arthroscopy System with HERMES Voice Control Classification Name: Surgical instrument motors and accessories/attachments
-
- The SE5 Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically designed for intra-articular debridement. A common control console powers the SE5 Shaver Handpiece. The SE5 Arthroscopy System is intended to be used by surgeons in orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint. It will be used to resect tissue and bur bone. The voice activation system is substantially equal to AESOP voice activation system. With this upgrade there are no new issues of safety and effectiveness.
- The Stryker SE5 Arthroscopy System with HERMES OR Control Center is designed and tested to the following Computer Motion and voluntary standards.
- IEC 601-1 Second Edition 1988 International Standard for Medical Electrical Equipment .
- IEC 601-1 Amendment 1 1991 International Standard for Medical Electrical Equipment .
- IEC 601-2-18 First Edition 1990 International Standard for Medical Electrical Equipment .
- . UL 2601-1
- EMC Directive European Union 89/336/EEC ●
- CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 ●
- HERMES Voice control System Functional Test Requirements .
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and appears above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1998
Mr. Salmaan Hameed ·Project Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K974771 Trade Name: Stryker SE5 Arthroscopy System With 'Hermes' Voice Control Regulatory Class: II Product Code: GCJ April 3, 1998 Dated: Received: April 7, 1998
Dear Mr. Hameed:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 (Premarket Approval), 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 895. ਸੈਂ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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.
2
Paqe 2 - Mr. Salmaan Hameed
This letter will allow you to begin marketing your device as described in your 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 requlation (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 device, 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,
Cecelia M. Witton, Ph.D.
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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Page 1 _______________________________________________________________________________________________________________________________________________________________________
K97477 510(k) Number (if known):
Device Name: Stryker SE5 Arthroscopy System with 'Hermes' voice control
Indications For Use:
Indications for use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
(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 | K984771 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use