(85 days)
No
The 510(k) summary describes a mechanical introducer device and does not mention any AI or ML components or functionalities.
No
The device is described as an introducer to permit passage of other devices for diagnostic and surgical procedures, not to provide therapy itself.
No
Explanation: The device is an introducer for passage of other devices to perform procedures, not for diagnostic purposes itself. While it facilitates diagnostic procedures, it does not directly perform them.
No
The device description clearly outlines physical components (stepped dilator, external sheath, Luer hub, rotating locking collar), indicating it is a hardware 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 clearly states the device is for "permitting direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures... in the urinary tract." This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a physical introducer system (dilator and sheath) designed to facilitate access to the urinary tract. This is consistent with a surgical or procedural device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to determining the presence or absence of a disease or condition through in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide access for other instruments during procedures.
N/A
Intended Use / Indications for Use
CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.
Product codes
78LJE, 79GBO, 78FEZ, 78KOB, 78EYB, 78GBL, 78GBM, 78KOD, 79GCC, 78EZN, 78KOE, KNY
Device Description
The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of fluids or a guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
July 3 0 1998
510(k) Summary: #K981611
CIRCON SURGITEK Snap-N-Peel™ Introducer
(Introducer Sheath & Dilator)
- Name of Submitter: CIRCON SURGITEK Division of Circon Corporation 1)
| Address: | 3037 Mount Pleasant Street | |
|---|---|---|
| Racine, WI 53404 |
(414) 639-7205 Telephone:
- Dr. Ronald J. Ehmsen Contact Person: Vice President, Regulatory Affairs Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117
Telephone: (805) 961-3290 Fax: (805) 968-7385
Date Submitted: July 14, 1998
- Name of Device: Introducer Sheath and Dilator 2)
Proprietary/Trade Name: Snap-N-Peel™ Introducer
Common/Usual Name: Introducer Sheath and Dilator
Classification: Various (see attached table)
Classification Names: Various (see attached table)
-
- Name of Predicate or Legally Marketed Device:
The CIRCON SURGITEK Snap-N-Peel™ Introducer is substantially equivalent to the Cook Peel-Away® Introducer that was approved by FDA for marketing on October 18, 1996, under 510(k) No. K961904, and to the Microvasive® Banana Peel M Sheath that was approved by FDA for marketing on July 23, 1997, under 510(k) No. K971165.
- Name of Predicate or Legally Marketed Device:
1
510(k) Summary: #K981611 CIRCON SURGITEK Division of Circon Corporation Shap-N-Peel™ Introducers July 14, 1998 Page 2
Description of Device: 4)
The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of 新 戴 fluids or a guidewire.
Intended Use of Device: રો
CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.
୧) Comparison of Technological Characteristics:
CIRCON SURGITEK's Snap-N-Peel™ Introducers are substantially equivalent' to the legally marketed Cook Peel-Away® Introducers and the Microvasive® Banana Peel™ Sheaths. CIRCON SURGITEK's devices employ the same design considerations, materials of construction and operating principles. The CIRCON SURGITEK devices also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices and are supplied sterile, for single use. Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness. None of the devices actively delivers any form of energy to the patient.
"The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.
2
510(k) Summary: #K981611
CIRCON SURGITEK Division of Circon Corporation Snap-N-Peel™ Introducers Bily 14, 1998
Page 3
- 1998年4月
Classification Names
| CDRH
Standard Product
Nomenclature | Product
Code | Class |
|-----------------------------------------------------------|-----------------|-------|
| Catheter,
Nephrostomy | 78LJE | II |
| Catheter,
Nephrostomy,
General & Plastic
Surgery | 79GBO | I |
| Catheter and Tube,
Suprapubic | 78FEZ | II |
| Catheter,
Suprapubic and
Accessories | 78KOB | II |
| Catheter, Ureteral,
Gastro-Urology | 78EYB | II |
| Catheter, Ureteral,
General & Plastic
Surgery | 78GBL | II |
| Catheter, Urethral | 78GBM | II |
| Catheter,
Urological | 78KOD | II |
| Dilator, Catheter | 79GCC | I |
| Dilator, Catheter,
Ureteral | 78EZN | II |
| Dilator, Urethral | 78KOE | II |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 1998
Ronald J. Ehmsen, Sc.D. ·Vice President, Regulatory Affairs Circon Corporation 6500 Hollister Avenue Santa Barbara, California 93117
Re: K981611 Trade Name: Snap-N-Peel Introducers Regulatory Class: II Product Code: KNY Dated: May 4, 1998 Received: May 6, 1998
Dear Dr. Ehmsen:
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 (OS) 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.
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.
4
Page 2 - Dr. R.J. Ehmsen
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,
tbolle
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/1 description: The image shows a series of bold, black symbols or characters against a white background. The symbols appear to be stylized and possibly handwritten, with varying shapes and sizes. There are seven distinct symbols, some of which resemble letters or numbers, while others are more abstract.
F. 277
510(k) Number: K981611
Device Name: CIRCON SURGITEK Snap-N-PeelTM Introducers
Indications for Use:
ﺮ ﺍﻟﻤﺴﺎﺑﻘﺎ
CIRCON SURGITEK's Snap-N-Peel™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical. procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract. a september 2017 - 11:20 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office od Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801,109)
OR
Over-The-Counter Use__
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981611