The REVIVE™ Intermediate Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Device Description

The REVIVE™ Intermediate Catheter is a variable stiffness, single lumen catheter designed to aid the physician in access to vasculature and in the delivery and retrieval of devices. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires. The Revive IC may also be delivered through the lumen of a larger bore guiding catheter. The catheter has an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories.

AI/ML Overview

This document is a 510(k) summary for the REVIVE™ Intermediate Catheter, submitted to the FDA. It establishes substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and reported performance for a new device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a new, novel device's performance study is not available here.

However, based on the provided text, I can infer the acceptance criteria were that the device performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness, as demonstrated by preclinical testing. The study that "proves" this is the series of preclinical tests conducted by Codman & Shurtleff, Inc.

Here's a breakdown of the requested information, addressing what is present and what is absent in the provided 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of specific numerical acceptance criteria and corresponding numerical reported device performance for each test. Instead, it states that "The REVIVE IC met all the biocompatibility requirements..." and "Results of verification and validation conducted on the REVIVE IC demonstrate that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new issues of safety and effectiveness."

Inferred "Acceptance Criteria" (Implicit from the text):

Device performs as designed.
Device is suitable for its intended use.
Device is substantially equivalent to predicate devices (ENVOY Guiding Catheter, Courier Microcatheter).
Device does not raise any new issues of safety and effectiveness.
Device meets all biocompatibility requirements as specified by ISO 10993 Part I and G95-1.
Device successfully passes all listed physical and mechanical tests.

Reported Device Performance (Implicit from the text):

"...demonstrate that it performs as designed..."
"...is suitable for its intended use..."
"...is substantially equivalent to the predicate device..."
"...does not raise any new issues of safety and effectiveness."
"The REVIVE IC met all the biocompatibility requirements..."
(Implied: The REVIVE IC successfully passed all the conducted tests detailed in the "Testing Summary".)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the preclinical tests.
The data provenance is from Codman & Shurtleff, Inc., which is based in Raynham, MA. The study appears to be prospective in nature, as it involves testing a newly developed device against pre-established criteria.

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 information is not applicable/not provided. This 510(k) relies on preclinical engineering and biological testing, not on human expert interpretation of data to establish a "ground truth" for a test set in the way a diagnostic AI device might. The "ground truth" for these tests would be established by validated test methods and reference standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving multiple human readers to resolve discrepancies in diagnoses or assessments. This document describes preclinical engineering and biological tests, where such adjudication is not typically relevant.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This is a 510(k) for an intermediate catheter, which is a physical medical device, not a diagnostic AI device. The submission focuses on physical and biological performance for substantial equivalence.

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

This question is not applicable. This device is a physical catheter, not an algorithm or AI system.

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

For the preclinical tests, the "ground truth" is established by adherence to validated test methods and industry standards. For example:

Biocompatibility: ISO 10993 Part I and General Program Memorandum # G95-1 (reference standards).
Physical/Mechanical Tests: The specific methods for "Shaft Kink Resistance," "Flow Rate Test," etc., would serve as the "ground truth" or reference for evaluating performance, though the specific standards or internal protocols are not detailed.

8. The sample size for the training set

This information is not applicable/not provided. This is a physical medical device, and the concept of a "training set" is not relevant in the context of its preclinical testing for 510(k) clearance based on substantial equivalence to predicate devices.

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

This information is not applicable/not provided, as there is no "training set" in the context of this device's regulatory submission.

Summary

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K 112828

OCT 2 5 2011

SECTION 5. 510(k) Summary

(As Required By 21 CFR 807.92(a))

A. Submitter Information

Submitter's name:	Codman & Shurtleff, Inc.
Address:	325 Paramount DriveRaynham, MA 02767
Telephone:	508-828-3312
Fax:	508-977-6428
Contact Person:	Catherine Kilshaw
Date of Submission:	September 23, 2011

B. Trade/Device Name:	REVIVE™ Intermediate Catheter
Common Name:	REVIVE™ Intermediate Catheter
Classification Name:	Percutaneous Catheter
Regulation Number:	Class II per 21 CFR 870.1250

C. Predicate Devices:

Device	Company	510(k) Number/Concurrence Date	ProductCode	Predicate For:
ENVOY®GuidingCatheter	Codman & Shurtleff,Inc.	K982770	DQY	Intended UseDesignMaterialsSterilization
Courier ®Microcatheter	Codman & Shurtleff,Inc (PreviouslyMicrusEndovascular, Corp)	K060116	DQY	Materials

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D. Device Description:

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E. Intended Use:

The REVIVE™ Intermediate Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

F. Summary of technological characteristics of the proposed to the predicate device:

The REVIVE Intermediate Catheter is substantially equivalent to the Codman ENVOY Guiding Catheter and the Courier Microcatheter. No new technological characteristics are being introduced with the proposed device.

The REVIVE IC has the same intended use as the ENVOY Guiding Catheter and it is similar with regard to design, materials, manufacturing and sterilization process. Both the REVIVE IC and the ENVOY feature a nylon body which is reinforced with stainless steel. REVIVE's multiple levels of stiffness from the highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires. This is similar to ENVOY which has three transition segments comprised of various durometers, along with a radiopaque filler. Both devices contain a soft, atraumatic distal tip.

In addition, the REVIVE IC is similar to the Courier Microcatheter with regard to materials. The base materials of the four major components of the REVIVE IC (hub & shaft, PTFE liner, stainless steel reinforcement, hydrophilic coating) are identical to the Courier.

All three devices are PTFE lined, have either a metallic braid or coil reinforcement, a polymer jacket of decreasing durometer from proximal to distal end, and a radiopaque marker at the distal tip. They are all EtO sterilized, packaged in a tyvek pouch and mounted either in a mounting card or plastic hoop.

G. Testing Summary:

Preclinical testing data to demonstrate that the device performs according to its description and intended use were used to establish the performance characteristics

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of the modifications to this device. Clinical testing was not required to establish substantial equivalence.

Results of verification and validation conducted on the REVIVE IC demonstrate that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new issues of safety and effectiveness. The following tests were conducted:

Shaft Kink Resistance .
Kink Resistance at Proximal End .
Catheter Lumen Patency .
Ability to Track to Target Sites .
Fluoroscopic Verification .
Trackability .
Catheter Length Verification .
Catheter Diameter Verification .
Compatibility with Guiding Catheters �
. Compatibility with Microcatheters
Luer Tapering .
Hub Transitioning ●
Hub Attachment Tensile Strength® > �
Shaft Tensile Strength .
. System Liquid Air Leakage
System Air Leakage .
Tip Atraumaticity .
. Coating Integrity
. Burst Test
Flow Rate Test .

The REVIVE IC met all the biocompatibility requirements as specified by the ISO 10993 Part I, and the General Program Memorandum # G95-1 on Biological Evaluation of Medical Devices. The following tests were conducted:

Cytotoxicity .
Sensitization .
Irritation .
. Systemic Toxicity
Hemocompatibility .

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Thrombogenicity .
Genotoxicity .

Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Codman & Shurtleff, Inc., it is concluded that the REVIVE Intermediate Catheter is substantially equivalent to the ENVOY Guiding Catheter and the Courier Microcatheter and therefore, does not raise any new issues of safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

OCT 2 5 2011

Codman & Shurtleff, Inc. c/o Ms. Catherine Kilshaw Regulatory Affairs Specialist II 325 Paramount Dr. Raynham, MA 02767-0350

Re: K112828

Trade/Device Name: REVIVE™ Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 26, 2011 Received: September 28, 2011

Dear Ms. Kilshaw:

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.

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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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Melvin R. Feldman, M.D.

Malvina B. Evdelman. M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112828

Device Name: REVIVE™ Intermediate Catheter

Indications For Use:

The REVIVE™ Intermediate Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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KII2828 510(k) Number .

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).