(160 days)
No
The summary describes a surgical power tool system for cutting, drilling, and reaming bone and tissue, and does not mention any AI or ML capabilities.
No
The device is described as being used for surgical procedures such as cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue, as well as for debriding synovitis, articular cartilage flaps, or torn ligaments. While these actions are part of medical treatment, the device itself is a surgical tool enabling these actions, rather than directly providing a 'therapeutic' effect (like drug delivery or radiation therapy). It is an instrument used by surgeons to perform therapeutic procedures.
No
The device is described as an instrument for surgical procedures involving the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone-related tissue, as well as for the placement of fixation devices. Its functions are entirely therapeutic and interventional, rather than diagnostic.
No
The device description clearly indicates the system is used for cutting, drilling, reaming, etc., of bone and tissue, and placement of fixation devices. This involves physical interaction with the patient's body, requiring hardware components like drills, reamers, shavers, etc., which are not software-only.
Based on the provided information, the Stryker HERMES-Ready™ Total Performance System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures involving cutting, drilling, reaming, etc., of bone and other tissues, as well as placing fixation devices and cutting metal. This is a direct surgical intervention on the patient's body.
- Device Description: The description reiterates the surgical applications of the device.
- 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 for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Stryker HERMES-Ready™ Total Performance System is a surgical device used for direct intervention on a patient, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The endoscopic applications with TPS include use of the SES 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
DZI, EIA, ERL, HBC, HBC, HBE, HWE
Device Description
Proprietary Name: Stryker HERMES-Ready™ Total Performance System Common Name is Stryker HERMES-Ready™ Total Performance System Classification Name: Surgical instrument motors and accessories/attachments
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and other bone related tissue, joint, wrist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974771, K973700, K980787, K942956, K943540, K943589, K943563/S2, K943541
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
OCT 25 1999
Premarket Notification 510(k) Safety and Effectiveness Summary 9
Stryker HERMES-Ready™ Total Performance System 510(k)
Stryker Instruments is submitting the following safety and effectiveness summary.
- Submitter Information:
Stryker Instruments 4100 E. Milham Ave. Kalamazoo, MI 49001 (616) 323-7700 Contact: Nicole Petty Prepared: March 12, 1999
- Name of Device:
Proprietary Name: Stryker HERMES-Ready™ Total Performance System Common Name is Stryker HERMES-Ready™ Total Performance System Classification Name: Surgical instrument motors and accessories/attachments
-
- Substantially equivalent to Stryker SE5 Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMESTM 510/k)'s K973700 and K980787. and Stryker Total Performance System K942956. K943540, K943589, K943563/S2, K943541.
The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, 4) reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often used in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include 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.
- Substantially equivalent to Stryker SE5 Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMESTM 510/k)'s K973700 and K980787. and Stryker Total Performance System K942956. K943540, K943589, K943563/S2, K943541.
- The Stryker HERMES-Ready™ Total Performance System will be designed and tested to the following voluntary standards.
- IEC 601-1 Medical Electrical Equipment General Requirements for Safety ●
- IEC 601-1-1 Medical Electrical Equipment Collateral Standard: Safety Requirements for Electrical ● Systems
- Medical Electrical Equipment Collateral Standard: Electromagnetic Compatibility ● IEC 601-1-2 Requirements and Tests
- . IEC 601-1-4 Medical Electrical Equipment - Collateral Standard: Requirements for Programmable Electronic Systems
- UL 2601-1 -- UL Standard for Safety for Medical Electrical Equipment -- General Requirements for Safety . (US Deviations for IEC 601-1)
- . CAN/CSA-C22.2 NO. 601.1-M90 - Medical Electrical Equipment General Requirements for Safety: A National Standard of Canada (Canadian Deviation for IEC 601-1)
1
10 Stryker HERMES-Ready™ Total Performance System Additional Appendix to User Manual
All other sections of the current User's Manual will remain unchanged.
Please refer to Tab A for the proposed appendix and current user instructions.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a bird in flight, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Ms. Nicole Petty Regulatory Affairs Analyst Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K991696
Trade Name: Stryker HERMES-Ready™ Total Performance System Regulatory Class: II Product Code: DZI, EIA, ERL, HBC, HBC, HBE, HWE Dated: September 16, 1999 Received: September 17, 1999
Dear Ms. Petty:
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 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 (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. A 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.
3
Page 2 - Ms. Nicole Petty
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 regulation (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,
fo callista
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
4
Page __ 1_ of __ 1____________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stryker HERMES-Ready™ Total Performance System
Indications For Use:
The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The endoscopic applications with TPS include use of the SES 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 | K991696 |
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |