(175 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical components and a console.
No
The device is used for cutting, drilling, reaming, decorticating, and smoothing bone and bone cement, as well as debriding tissue and managing osseous lesions. These actions are surgical interventions, not therapeutic treatments.
No
The device is described as being used for cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement, as well as placing or cutting screws, metal, wires, pins, and other fixation devices. These are all surgical interventions, not diagnostic activities.
No
The device description explicitly lists numerous hardware components, including drills, shavers, motors, console, and other physical accessories, indicating it is not a software-only device.
Based on the provided information, the Stryker Consolidated Operating Room Equipment (CORE) System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in surgical procedures involving cutting, drilling, reaming, etc., of bone and other materials within the body. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The components listed (drills, shavers, motors, saws, etc.) are surgical instruments used directly on the patient during a procedure.
- Anatomical Site: The anatomical sites mentioned (bone, bone cement, wrist, joint) are locations within the human body where the surgical procedures are performed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The device is a surgical tool used for treatment and manipulation of tissues and materials during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for 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
HBE
Device Description
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases.
The scope of this modification is limited to the console of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, bone cement, wrist (small joint), osseous lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room
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)
K943540, K943569, 943541, 991696, K012380, K771218
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
:
510(k) Summary
. -
大032303
| Trade Name: | Stryker Consolidated Operating Room Equipment (CORE) System |
|---|---|
| Common Name: | Console |
| Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section |
| 872.4120) | |
| Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per 21 | |
| CFR section 874.4250) | |
| Powered Simple Cranial Drill, Burrs, Trephines and their Accessories | |
| (per 21 CFR section 882.4310) | |
| Equivalent to: | Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), TPS |
| Hermes (991696), Stryker Navigation System (K012380) and Dyonics | |
| (K771218). | |
| Device Description: | The device description of the Stryker System includes drills, shavers, |
| shields, guards, motors, attachments, saws, wire drivers, collets, | |
| console, irrigation pump, cords, footswitch, handswitch, clips, tubing, | |
| cutting accessories, and sterilization cases. | |
| The scope of this modification is limited to the console of the system. | |
| Intended Use: | The Stryker Consolidated Operating Room Equipment (CORE) System |
| is intended for use in the cutting, drilling, reaming, decorticating, and | |
| smoothing of bone and bone cement in a variety of surgical | |
| procedures, including but not limited to Neuro and Endoscopic. It is | |
| also usable in the placement or cutting of screws, metal, wires, pins, | |
| and other fixation devices. | |
| The endoscopic applications with CORE include use with the SE5 | |
| Small Joint Shaver in the wrist for 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. | |
| Technological | |
| Comparison: | Technological characteristics are the same as previously cleared |
| for the Stryker TPS System (K943540, K943569, K943541, and | |
| K991696), Stryker Navigation System (K012380) and Dyonics | |
| (K771218). | |
| Submitted by: | Jean W. Sheppard |
| Sr. Regulatory Affairs Representative | |
| Stryker Instruments | |
| July 24, 2003 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.
JAN 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jean W. Sheppard Sr. Regulatory Affairs Representative Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K032303
Trade/Device Name: Stryker Consolidated Operating Room Equipment (CORE) Console Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and their accessories Regulatory Class: II Product Codc: HBE Dated: October 20, 2003 Received: October 21, 2003
Dear Ms. Sheppard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been worked the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to the enactment date of the Medical Device Amendments, or to conniner of the rial) 2011-11-3) in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Costiette Act (71ct) that to hot requestly of the general controls provisions of the Act. The r ou may, merelere, mainer of the Act include requirements for annual registration, listing of general controls provisions of are tice, 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 If your device is classified (500 abor of the existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of Counts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuated of a basenia.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations and annualing, but not limited to: registration and listing (21 comply with an the Act s requirements, me; good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Jean W. Sheppard
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your deversity your develop premarket nothcation. THE PDA Intellig of babbankal via revice 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 If you desire specific atvice for your do rice of the same of the regulation entitled, and comact the Office of Compliance an (21CFR Part 807.97). You may obtain "Whisoranding by relevelee to premail.org.ibilities under the Act from the Division of Small other general informational 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,
Miriam C. Provost
Colia 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
Indications for Use Statement
510(k) Number (if known): K032303
The Stryker Consolidated Operating Room Equipment (CORE) Device Name System
- The Stryker Consolidated Operating Room Equipment (CORE)System is Indications intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for 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.
Prescription Use _ X (Per 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR 807 Subpart C)
(IPLEASE DO NOT WRITE BELOW THISS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Sivision Sign-Off) Division of General, Restorative and Neurological Devices
K632303 (1) Number ...
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