(76 days)
Not Found
No
The summary describes a mechanical device for stiffening a colonoscope and makes no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device increases the stiffness of a colonoscope, which is a surgical tool, and does not directly treat a disease or condition in a patient.
No
Explanation: The device's intended use is to increase the stiffness of a colonoscope, which is an interventional function, not a diagnostic one. It aids in the procedure itself rather than in identifying a condition.
No
The device description explicitly states it is composed of materials and has dimensions, indicating it is a physical 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 is to "allow the physician to increase the stiffness of the colonoscope when extra rigidity is required." This describes a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description focuses on the device's function in stiffening a colonoscope and its physical characteristics (materials, dimensions).
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
- Image processing, AI/ML, or specific imaging modalities, which are often associated with certain types of IVDs (like digital pathology or imaging-based diagnostics).
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical and procedural, not analytical.
N/A
Intended Use / Indications for Use
The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
Product codes
KOG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colonoscope
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Steel Wire PreAmendment Device, K901610, K941973, K023603, K001241
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
Ko51068
510(k) Summary
(1) Contact Information
This 510(k) premarket notification is being submitted by Joseph Azary on behalf of Zutron Medical. The device is manufactured by Specialty Medical Systems, Inc.
Submitter / Regulatory Consultant: Joseph Azary, Azary Technologies LLC, 543 Long Hill Avenue, Shelton, CT 06484, Tel: 203-944-9320, Fax: 203-944-9317
Device Owner: Zutron Medical, 1911 Broadway, Kansas City, MO 64108
Manufacturer: Specialtv Medical Systems, Inc (SMS), 1911 Broadway, Kansas City, MO 64108, FDA Establishment Registration# 9010172
Establishment Registration for Zutron Medical is pending.
- (2) Device Information
- (3) Trade or Proprietary Name: Zutron Colonoscope Stiffening Device
Common Name: Stiffening Wire or Stiffening Device
Classified Name: Endoscope Accessories
(4) Predicate Devices:
- Steel Wire PreAmendment Device (medical articles dated as early as 1972 reference the use of steel . wires for the stiffening of colonoscopes)
- Guide Wires and Cables �
- Sullivan Variable Stiffness Cable, K901610, Wilson Cook Medical, Product Code KOG 0
- GIP / Medi-Globe Guide Wires, K941973, Medi-Globe Corp, Product Code FGE O
- GIP / Medi-Globe, Stiffy Variable Stiffness Guide Wire, 510(k) Unknown, Medi-Globe Corp, o Product Code not specified
- Endo-Glide Guidewire, K023603, Endo-Therapeutics Inc., Product Code KOG O
- . Colonoscopes with Stiffness Controls
- Olympus PCF-160AL/I, K001241, Olympus Optical, Product Code FDF ಂ
- (5) Intended Use: The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
- (6) Technological Characteristics: The Zutron Colonoscope Stiffening Device performs the same functions as several other devices on the market. Additionally, the subject device is composed of the same materials and has similar dimensions to some of the predicate devices.
- (7) Conclusion: We believe the differences are minor and conclude that the subject device is as safe and effective as the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows a black and white drawing of a bird in flight. The bird is facing to the right and has its wings spread. There is text in a circular pattern to the left of the bird. The text is not clear enough to read.
JUL 1 1 2005
Food and Orug Administration 9200 Corporate Boulevard Rockville MD 20050
Zutron Medical c/o Mr. Joseph M. Azary Regulatory Consultant Azary Technologies, LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K051068
Trade/Device Name: Zutron Colonoscope Stiffening Device Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: June 15, 2005 Received: June 20, 2005
Dear Mr. Azary:
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 and enormals, to regard man 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 do not require approval or of a 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 n your av, it may be subject to such additional controls. Existing major regulations affecting your Approvation of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA acrive but of round announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I toast be actised that i be rise complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I carates and reguirements, 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) (2) CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
JUL 1 2005
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to organization of substantial equivalence of your device to a legally premarked nothleadon: "The PDF masification 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 If you desire specific acrise to your and of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, proase note the regation on your responsibilities under the Act from the ov : 377. Tod may ooually ourers, 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 yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KOS1068
Indications for Use
510(k) Number (if known):
X051068
.
.
Zutron Colonoscope Stiffening Device Device Name:
Indications For Use:
The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
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)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
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