(60 days)
Not Found
No
The summary describes a simple heating device for endoscopes and contains no mention of AI or ML.
No
The device is used to heat endoscopes to minimize fogging, which is an accessory function for endoscopic procedures, not a therapeutic treatment for a disease or condition.
No
The device is described as an endoscopic accessory used to heat endoscopes to minimize fogging, which is a functional enhancement for visualization rather than a tool for diagnosing medical conditions.
No
The device description explicitly states it is composed of PVC and sodium acetate, indicating it is a physical hardware device, not software only.
Based on the provided information, the Stryker Scope Warmer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Stryker Scope Warmer's Function: The Stryker Scope Warmer is an accessory used to heat endoscopes to prevent fogging during surgical procedures. It interacts with the endoscope itself, not with a sample taken from a patient's body.
- Intended Use: The intended use clearly states it's for use with endoscopes prior to and during surgeries to minimize fogging. This is a functional aid for the surgical procedure, not a diagnostic test.
- Device Description: The description mentions PVC and sodium acetate, which are materials used for the device's construction and heating mechanism, not reagents or components for analyzing biological samples.
Therefore, the Stryker Scope Warmer falls under the category of a surgical accessory or instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Scope Warmer is indicated for use with endoscopes. As such, this product is indicated for use prior to and during surgeries in which an endoscope is indicated. The Stryker Scope Warmer is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope.
Product codes
GCJ
Device Description
The Stryker Scope Warmer is a new product developed by Stryker Scope Warmer is an endoscopic accessory, composed of PVC and sodium acetate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prior to and during surgeries
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.
0
stryker®
JAN 2 7 2006
Endoscopy
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Proprietary Name: | Stryker Scope Warmer |
|---|---|
| Common and Usual Name: | Endoscope Warmer, Instrument Warmer |
| Classification Name: | Endoscope and/or Accessories, Laparoscope, General & |
| Plastic Surgery |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA 1990.
The Stryker Scope Warmer is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including Applied Medical's Scope Warmer (K931895).
The Stryker Scope Warmer is a new product developed by Stryker Scope Warmer is an endoscopic accessory, composed of PVC and sodium acetate.
The Stryker Scope Warmer is indicated for use with endoscopes. As such, this product is indicated for use prior to and during surgeries in which an endoscope is indicated. The Stryker is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope.
The Stryker Scope Warmer conforms to the following voluntary safety and performance standards: ISO 10993. EN 550. ASTM D999. ASTM D1140. ASTM D4728. ASTM 5276. ASTM F88-94. EN 868-1, ISO 11607 and ASTM D4169.
The technological differences between the Stryker Scope Warmer and the identified predicate device (Applied Medical's Scope Warmer (K931895) do not affect the safety or efficacy of the product, therefore, the Stryker Scope Warmer is substantially equivalent to the identified predicate devices and surgery systems.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health, with three lines above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 2006
Ms. Crystal Ong Regulatory Affairs Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K053311
Trade/Device Name: Stryker Scope Warmer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 23, 2005 Received: December 7, 2005
Dear Ms. Ong:
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 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.
2
Page 2 - Ms. Ong
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" (21 CFR 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/industry/support/index.html.
Sincerely vours,
charlau bienn
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:_Stryker Scope Warmer
Indications For Use:
The Stryker Scope Warmer is indicated for use with endoscopes. As such, this product is indicated for use prior to and during surgeries in which an endoscope is indicated. The Stryker Scope Warmer is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope.
L Prescription Use (Part 21 CFR 801 Subpart D)
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)
Jarbare Muelin
(Division Sign)-Division of General, Restorative. and Neurological Devices
Page 1 of
510(k) Number K053311