(118 days)
The Gyrus ACMI Variable Length Access Sheath is 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.
Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath is a single use, sterile disposable product. The device consists of a sheath (manufactured from PTFE with BiOs) and dilator (manufactured from HDPE with BaS02) to facilitate the passage of catheters and other urological devices in the urinary tract. The sheath length is adjustable to the size necessary for the procedure. The dilator is attached to the sheath via a locking leur. The leur connector also allows for injection or irrigation or contrast fluid. For ease of visualization, the dilator and sheath are radiopaque.
The provided text describes a Special 510(k) Notification for the Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath and primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data in the traditional sense of a clinical or analytical performance study.
Therefore, many of the requested elements for a study showing device performance against acceptance criteria are not directly available in the provided text.
Here's an attempt to extract and infer information based on the given text:
1. A table of acceptance criteria and the reported device performance
The submission primarily relies on demonstrating substantial equivalence through non-clinical testing comparing the modified device to predicate devices. The "acceptance criteria" are implicitly that the modified device performs no worse than the predicate devices across relevant performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Materials are biocompatible. | Biocompatibility testing performed in compliance with ISO-10993. |
| No significant difference in technological features. | Incorporates the same technological features (peel away sheath, tapered dilator and locking mechanism with port) as previously cleared devices. |
| No significant difference in intended use. | Has the same Indications for Use as previously cleared devices. |
| Similar materials with established history of successful clinical application. | Uses similar materials (PTFE for sheath, HDPE for dilator - same as predicate but from different supplier). Materials have an established history in Urology. |
| Performance demonstrated to be substantially equivalent to predicate devices. | Nonclinical testing conducted, demonstrating no significant difference in performance compared to predicate devices. |
| No new issues of safety and effectiveness raised by modifications. | Non-clinical testing confirms that no new issues of safety and effectiveness have been raised by the proposed device modifications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "nonclinical testing" but does not specify sample sizes for these tests. It's also not a clinical study, so terms like "test set" in the context of clinical data are not directly applicable. The testing is likely laboratory-based. No country of origin or retrospective/prospective nature is mentioned, consistent with non-clinical, in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the submission describes non-clinical testing for substantial equivalence, not a study requiring expert-established ground truth on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as it's a non-clinical submission for substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an access sheath for urological procedures, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an access sheath, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would likely be the established performance characteristics and safety profile of the predicate devices, against which the new device's performance was compared. This comparison would be based on engineering specifications and material science, not clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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K 123170
Variable Length Access Sheath
Olympus Surgical Technologies of America Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification
FEB 0 4 2013
510(K) SUMMARY
General Information
Manufacturer
Contact Person:
Date Prepared:
Classification Name: Regulation / CFR Citation Number Product Code Class Review Panel
Trade Name:
Gyrus ACMI Inc. 136 Turnpike Rd. Southborough, MA 01772-2104 ERN: 3003790304
Deana Boushell (508) 804-2752 deana.boushell(@)Olympus-OSTA.com
October 28, 2012
Urological catheter and accessories 876.5130 KNY II Gastroenterology/Urology
Urological catheter and accessories
Gyrus ACMI Vari-PassTM Adjustable Length Access Sheath
Generic/Common Name:
Predicate Device
The predicate devices include: 1. Gyrus ACMI Snap-N-Peel™ Introducer 2. Gyrus ACMI Uropass®
Intended Use
The Gyrus ACMI Variable Length Access Sheath is 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 Description
Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath is a single use, sterile disposable product. The device consists of a sheath (manufactured from PTFE with BiOs) and dilator (manufactured from HDPE with BaS02) to facilitate the passage of catheters and other urological devices in the urinary tract. The sheath length is adjustable to the size necessary for the procedure. The dilator is attached to the sheath via a locking leur. The leur connector also allows for injection or irrigation or contrast fluid. For ease of visualization, the dilator and sheath are radiopaque.
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Technological features and Substanial Equivalence
The proposed Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath incorporates the same technological features (peel away sheath, tapered dilator and locking mechanism with port) as previously cleared devices.
The proposed Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath has the same Indications for use as previously cleared devices.
The Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath uses similar materials compared to the predicate. The sheath material was changed to PTFE from FTE and though the dilator matieral is the same (HDPE) it is being sourced from a different supplier. These materials have an established history of successful clinical application in Urology. Biocompatibility testing has been performed in compliance to the relevant requirements of ISO-10993.
Nonclinical Testing and Performance Data
Nonclinical testing has been conducted and performance data demonstrates no significant difference in the performance of Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath as compared to predicate devices.
Summary
The proposed Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath, as described in this submission, is substantially equivalent to the predicates in intended use, materials, principles of operation and fundamental scientific technology . Non-clinical testing confirms that no new issues of safety and effectiveness have been raised by the proposed device modifications.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2013
Olympus Surgical Technologies America Gyrus ACMI, Inc. % Ms. Deana Boushell Senior Regulatory Specialist 136 Turnpike Road SOUTHBOROUGH MA 01772
Re: K123170
Trade/Device Name: Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: December 3, 2012 Received: December 4, 2012
Dear Ms. Boushell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert ﻡ Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
23170
Device Name: Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath
Indications for Use:
Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath is 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.
Prescription Use: __ X
OR
Over-the-Counter Use:
(Per 21 CFR 801.109)
(PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P.Lerner -S
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K123170
§ 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.