The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

Device Description

The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.

AI/ML Overview

The provided documentation is a 510(k) summary for the ROCAMED RocaUS Platinum, a ureteral access sheath. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the same way a new AI/ML-driven diagnostic device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this document because it is not a clinical study report for a diagnostic or treatment outcome device. The "performance data" referred to in this document relates to physical and functional testing, not clinical performance measures like accuracy or sensitivity.

Here's an attempt to fill in the table and address the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a medical device (ureteral access sheath) demonstrating substantial equivalence, the "acceptance criteria" are primarily met through comparison to predicate devices across technological characteristics and intended use, supported by physical and functional testing. There are no explicit performance metrics like sensitivity, specificity, or accuracy derived from a clinical study with a test set that would have numerical acceptance criteria.

Acceptance Criteria Category	Reported Device Performance (ROCAMED RocaUS Platinum)
Intended Use	Conduit for passage of endoscopes and other urological devices for performing ureteroscopy procedures. Dual working lumen dilator allows guidewire and fluid insertion.
Technological Characteristics	- Disposable, sterile, X-ray opaque, coil reinforced, atraumatic tip, tapered dilator, radiopaque marks, hydrophilic coating, injection of contrast media, proximal end funnel. - 2 lumens - Dilator Material: LDPE+BaSO4 - Sheath Material: Pebax-SST-PTFE - Fr Size: 10/12, 12/14 - Length: 35 cm - Guidewire compatibility: 0.032", 0.035"
Safety	Implied by substantial equivalence to legally marketed predicate devices and successful physical/functional testing. Changes in dilator material (LDPE instead of PTFE) stated to "ease insertion into the patient and reduce trauma."
Performance (Functional)	Results of physical and functional testing support substantial equivalence. (Specific reported performance values for these tests are not detailed in this summary).
Materials	Materials chosen are considered substantially equivalent or improved (e.g., LDPE for dilator) compared to predicate devices, based on physical and functional testing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This document refers to physical and functional testing, not a clinical test set of patient data. The specifics of samples used for these engineering tests (e.g., number of devices tested for tensile strength or burst pressure) are not provided in this summary.
Data Provenance: Not applicable for clinical test data. The physical and functional testing would have been conducted by Promepla SAM.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., pathology, expert consensus on images) is not relevant for this type of medical device submission, which relies on physical and mechanical properties and comparison to predicates.

4. Adjudication method for the test set

Not applicable.

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 not an AI-assisted diagnostic tool and therefore did not undergo an MRMC study related to AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance would be against engineering specifications and predicate device characteristics, verified through physical and functional testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm.

Summary

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MAY 1 4 2012

K120160/S001

Submitter : Promepla SAM

RocaUS Sheath Traditional 510 (k)

510 (k) Summary

A. Submitter Information:

Submitter's Name: Address:

Contact Person: Contact Person's Number: Contact Person's Fax: Date of Preparation:

PROMEPLA SAM 9 Avenue Prince Albert II "LE COPORI" MC 98000 MONACO (Principality of) David Tripodi (377) 97984233 (377) 92056150 January 14, 2012

B. Device Name:

Trade Name: Common Name: Classification Name(s): Produce Code: CFR Reference:

ROCAMED RocaUS Platinum · Ureteral Access Sheath Accessories, Catheter, G-U KNY 21 CFR 876.5130

C. Predicate Device Name:

Trade Names:

AMCI UroPass Ureteral Access Sheath (K051593) Boston Scientific Navigator Access Sheath Set II (K030956)

D. Device Description:

E. Intended Use:

F. Technological Characteristics Summary:

The ROCAMED RocaUS Platinum is flexible coil reinforced sheath with hydrophilic coating. The device can be inserted by placing the dilator/sheath assembly over a guidewire, inserting it into the patient and unclipping the dilator from the sheath and removing the sheath in place. The sheath allows for safe passage of endoscopes, injection of fluids and other related instruments.

Table 1 provides a comparison summary of the technological characteristics of the ROCAMED RocaUS Platinum versus the predicate devices.

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Submitter . Promepla SAM

RocaUS Sheath Traditional 510 (k)

Table 1

Summary of Equivalence of the ROCAMED RocaUS Platinum to Predicate Devices

	Proposed Device	Predicate Device	Predicate Device
Product Name	ROCAMED RocaUSPlatinum	AMCI UroPassUreteral AccessSheath	BSCI Navigator AccessSheath Set II
510(k) Number		K051593	K030956
Product Code,Regulation #,Name	KNY21 CFR 876.5130,Urological catheter andaccessories.	KNY21 CFR 876.5130,Urological catheter andaccessories.	KOG21 CFR 876.1500,Endoscope andAccessoriesGBM21 CFR 876.5130,Urological catheter andaccessories.
Manufacturer	Promepla SAM	Gyrus ACMI	Boston Scientific
Intended Use	The ROCAMEDRocaUS Platinum isintended to be aconduit for passage ofendoscopes and otherurological devices forthe purpose ofperformingureteroscopyprocedures. The dualworking lumen dilatorwith luer lockconnections allows theuser to insertguidewires and fluids.	The UroPass UreteralAccess Sheath isintended to be aconduit for the passageof endoscopes andother urologicaldevices for the purposeof performingdiagnostic and surgicalprocedures such asnephrostomy,cystoscopy, orureteroscopy, in theurinary tract.	The UASS II isindicated for use inendoscopic proceduresto facilitate thepassage ofendoscopes, urologicalinstruments and for theinjection of fluids intothe urinary tractantegrade and/orretrograde access.
Reuse Status	Disposable. For singlepatient use only	Disposable. For singlepatient use only	Disposable. For singlepatient use only
Sterile	Yes	Yes	Yes
Lumen	2	1	1
Dilator Material	LDPE+BaSO4	PTFE+ BaSO4	PTFE+ BaSO4
Sheath Material	Pebax-SST-PTFE	SST-PTFE	SST-PTFE
X-Ray Opaque	Yes	Yes	Yes
Coil Reinforced	Yes	Yes	Yes
Fr Size	10/12,12/14	12/14	11/13, 13/15

Length	35 cm	24, 38, 54 cm	28, 36, 46 cm
Guide wire	0.032", 0.035"	Yes	0.035", 0.038"
Compatibility
Atraumatic Tip	Yes	Yes	Yes
Tapered Dilator	Yes	Yes	Yes
Radiopaque Marks	Yes	Yes	Yes
Hydrophilic Coating	Yes	Yes	Yes
Injection of ContrastMedia	Yes	Yes	Yes
Proximal End Funnel	Yes	Yes	Yes

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K120160/S001

Submitter : Promepla SAM

RocaUS Sheath

Traditional 510 (k)

Dilator material is different from the predicate devices, LDPE instead of PTFE. It was selected instead of PTFE because it is slightly more flexible, which will ease insertion into the patient and reduce trauma.

G. Performance Data:

Results of physical and functional testing support a determination of substantial equivalents for the ROCAMED RocaUS Platinum when compared to the predicate devices. The ROCAMED RocaUS Platinum is substantially equivalent to devices currently market approved in terms of intended use, technology, principles of operation and materials.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Krista Johnson . Quality Group - Regulatory Affairs PROMEPLA SAM LE COPORI - 9 Avenue Prince Albert II MONACO MC 98000 MONACO

MAY 1 4 2012

Re: K120160 Trade/Device Name: ROCAMED RocaUS Platinum

Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY, KOD Dated: May 4, 2012 Received: May 7, 2012

Dear Ms. Johnson:

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 hiability 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. 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K-twke

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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K120160/S001

Submitter : Promepla SAM

RocaUS Sheath Traditional 510 (k)

Indications for Use Statement (K98-1)

510(k) Number (if known):
---------------------------	--

Device Name: ROCAMED RocaUS Platinum

Indication for use:

The ROCAMED RocaUS Platinum is intended to be a conduit.for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

Prescription Use __ X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE 6 CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Grant Barr for Benjamin Fisher
(Division Sign-Off)

actro-Ren.

Regulation Number and Section

§ 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.