It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein.

Device Description

The Split Cath® Rg Long Term Catheter provides two dedicated (arterial/venous) access lumens. Each lumen is connected through an extension line with female luer connectors. The transition between lumen and extension is housed within a molded hub. To prevent recirculation, the venous end of the lumen is approximately 1.0" longer than the arterial. The catheter is capable of providing consistent flows up to 400ml/min.

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material that is rigid upon insertion and once it reaches body temperature becomes soft to reduce vessel trauma.

The dialysis extensions are color coded with a white luer, red sleeve, and red clamp for the arterial lumen. The easy identification of the venous lumen, there is a white luer, blue sleeve, and blue clamp.

The proposed device is 14 French in size and comes in the following lumen lengths: 24.28. 32, 36, and 40cm. The catheter is packaged in separate components as they are assembled during retrograde insertion. After the lumen is inserted, it is attached to the Attachable Hub and Extension Assembly using the Lumen Clamp.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called the MEDCOMP® Split Cath® Rg. It describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain the detailed acceptance criteria or the study results in the format requested, specifically for an AI/CAD/ML device.

This document is for a blood access catheter, which is a physical medical device, not an AI/CAD/ML software or system. Therefore, the specific questions regarding AI/CAD/ML device performance (sample size for test/training sets, experts for ground truth, MRMC comparative effectiveness, standalone performance, etc.) are not applicable to this submission.

Despite the non-applicability of some questions, I will extract the relevant information regarding performance criteria and testing as presented in the document for the physical device.

Acceptance Criteria and Device Performance (for a physical medical device, not AI/CAD/ML)

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a physical blood access catheter. The "Performance Standards" section explicitly states: "Performance standards have not been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act."

Instead of acceptance criteria for diagnostic performance (like sensitivity/specificity), the document details non-clinical bench testing to ensure the safety and effectiveness of the physical device, especially considering a change in insertion method (retrograde vs. antegrade) and the presence of a new stainless steel cannula.

Here's a summary of the reported information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test (Nonclinical)	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993	"Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993."
0 Air Leakage	No Air Leakage	Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing.
_ Liquid Leakage	No Liquid Leakage	Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing.
_ Force at Break	Meets force requirements	Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing.
_ Recirculation	Meets recirculation limits	Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing.
_ Flow vs. Pressure	Achieves consistent flows up to 400ml/min	"The catheter is capable of providing consistent flows up to 400ml/min." (This is a design specification, not a test result, but implies the test would confirm it).
_ Priming Volume	Meets specified priming volume	Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing.
Mechanical Hemolysis	Acceptable hemolysis levels (due to change in blood flow path)	"mechanical hemolysis testing was performed on the proposed device... Furthermore, the proposed device was evaluated for MRI safety..." (No specific numeric result given, but the submission implies acceptable results for substantial equivalence).
MRI Safety	Safe for MRI (due to stainless steel cannula)	"the proposed device was evaluated for MRI safety due to the presence of the stainless steel cannula." (No specific result given, but the submission implies acceptable results for substantial equivalence).
Hub Assembly Integrity	Sure fit of cannula to lumen, followed by compression ring and hub clamps	"The sure fit of this cannula to lumen, followed by application of the compression ring and hub clamps, is essential to device integrity following the insertion and assembly procedure." (This is a design objective, and successful testing is implied for substantial equivalence).

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

Sample Size: Not specified in the document. The testing described is non-clinical bench testing.
Data Provenance: N/A for this type of physical device testing. The tests are bench tests performed on the device itself.

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

Not applicable (N/A). This is a submission for a physical medical device. "Ground truth" in the context of expert consensus for AI/CAD/ML algorithms is not relevant here. The "ground truth" for these tests are objective measurements (e.g., leakage, force, flow rates, ISO standards adherence).

4. Adjudication method for the test set

Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for expert consensus on AI/CAD/ML ground truth, not for physical device bench testing.

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 (N/A). This is for a physical medical device, not an AI/CAD/ML system.

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

Not applicable (N/A). This is for a physical medical device, not an AI/CAD/ML system.

7. The type of ground truth used

Not applicable (N/A). For this physical device, "ground truth" is established by objective engineering and material science standards, measurements, and adherence to performance specifications (e.g., ISO standards for biocompatibility, measured flow rates, leakage tests).

8. The sample size for the training set

Not applicable (N/A). This is a physical medical device. There is no "training set."

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

Not applicable (N/A). This is a physical medical device. There is no "training set" or "ground truth" in the AI/CAD/ML sense.

Summary

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DEPARTMENT OF HEALTH & IIUMAN SERVICES

Public Health Service

Food and Dree Administration 10903 Now Hamoshing Avenue Doeument Caniral Center - WO66-G60 Suver Spring, MD 20991-00002

April 28. 2014

MEDCOMP® Timothy Holvick Regulatory Associate 1499 Delp Drive Harleysville, PA 19438

Re: K130889

Trade/Device Name: Split Cath® Rg Regulation Number: 21 CFRS 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: March 17. 2014 Received: March 18, 2014

Dear Timothy Holwick,

We have reviewed your Section 510(k) nremurket 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 cnaciment 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 upplication (PMA). You may, therefore, market the device. subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially cquivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976. the enacunent date of the Medical Device Amendmens. Please note: If you purchase your device components in bulk (i.c., unfinished) and further process (c.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and 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 cither 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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Page 2 - Timothy Holwick

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. 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 P. Lerner-S

for

Beniamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image shows the logo and contact information for Medcomp. The address is 1499 Delp Drive, Harleysville, PA 19438. The phone number is 215-256-4201, the fax number is 215-256-1787, and the website is www.medcompnet.com.

Indications for Use

510(k) Number (if known): K130889

Split Cath® Ry Device Name:

Indications for Use:

The Medcomp Split Cath® Ry is indicated for use in attaining Long-Term vascular access for Hemodialysis und Apheresis in the adult patient.

It may be inserted perculuneously and is primarily placed in the internal jugular vein. Altemate insertion sites include the subclavian vein and femoral vein.

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

Over-The-Counter Usc (2) CFR 801 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.04.28 16:20:38 -04'00' Page 1 of

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Image /page/3/Picture/0 description: The image shows a logo for a company called "medcomp". The logo is a stylized letter "M" that is made up of geometric shapes. The letter "M" is in gray, and the background is white. The word "medcomp" is written in lowercase letters below the logo.

edCOMP

1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax. 215-256-1787

www.medcompnet.com

Section 5 510(k) SUMMARY Submitter Information: Submitter: MEDCOMP@ 1499 Delp Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Timothy Holwick. Regulatory Associate Date Prepared: March 25, 2013 Device Name: Split Cathe Ra

Traditional 510K

Device Name:	Split-Cath® Rg
Common Name:	Catheter, Hemodialysis, Implanted
Classification Name:	Blood Access device and accessories
C.F.R. Section:	876.5540
Classification Panel:	Gastroenterology and Urology
Class:	III, MSD

Predicate Devices:

Contact:

K121848, Split Cath® III concurrence date September 21, 2012. Class III CFR 8876.5540 K 022678 Split Cath IV (Split Stream), concurrence date February 24, 2003 Class III CFR $876.5540

Device Description:

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material that is rigid upon insertion and once it reaches body temperature becomes soft to reduce vessel trauma.

Intended Used:

The Medcomp Split Cath® Rg is intended for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patient.

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Image /page/4/Picture/0 description: The image shows an abstract design with geometric shapes. The design features a combination of curved and straight lines, creating a sense of depth and dimension. The shapes are arranged in a way that suggests a sense of movement and flow. The overall composition is visually striking and intriguing.

eCOMH

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Indications for Use:

The Medcomp Split Cath® Rg is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in the adult patient.

If may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein.

Comparison to Predicate Devices:

The Split Cath® Rg is substantially equivalent to the predicate devices in terms of intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.

ATTRIBUTE	Split Cath RG (Proposed Device)	Split Cath III K121848(Predicate Device)
INDICATIONSFOR USE	The Medcomp Split Cath Rg isindicated for use in attaining Long-Termvascular access for Hemodialysis andApheresis.	The Medcomp Split Cath III isindicated for use in attaining longterm vascular access forHemodialysis and Apheresis in theadult patient.
TARGETPOPULATION	Adult	Adult
INSERTION SITE	Internal jugular veinSubclavian vein	Internal jugular veinSubclavian veinFemoral veinTranslumbar
WHERE USED	Hospital	Hospital
STERILIZATIONMETHOD	100% Ethylene Oxide	100% Ethylene Oxide
MATERIAL /ADDITIVES	Lumen - Polyurethane: ChronoFlexCuff - PolyesterHub/Suture Wing and Luers: IsoplastExtension: PolyurethaneClamps - AcetalExtension Sleeve - SiliconeCannula and Pins - Stainless Steel	Lumen - Polyurethane: ChronoFlexCuff - PolyesterHub and Suture Wing -PolyurethaneExtension - PolyurethaneClamps - AcetalLuers - IsoplastExtension Sleeve - Silicone
DESIGNSPECIFICATION	LUMEN: 14FLUMEN LENGTHS: 24, 28, 32, 36, and40cm	LUMEN: 14FLUMEN LENGTHS: 20, 22, 24, 28,32, 36, 40, and 55cm

Performance Standards:

Performance standards have not been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act.

Biocompatibility:

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Image /page/5/Picture/0 description: The image shows an abstract design with geometric shapes. The design features a combination of curved and angular elements, creating a sense of depth and dimension. The shapes are filled with a gradient of gray, adding to the visual complexity of the image. The overall composition is visually striking and evokes a sense of modern art.

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.

Nonclinical Testing:

Performance Bench Testing:

0 Air Leakage
ହ Liquid Leakage
0 Force at Break
电 Recirculation
国 Flow vs. Pressure
Priming Volume 0

In addition to the above testing, mechanical hemolysis testing was performed on the proposed device due to the change in blood flow path when compared to the predicate device. Furthermore, the proposed device was evaluated for MRI safety due to the presence of the stainless steel cannula.

Technological Characteristics:

The proposed device is intended for retrograde insertion whereas the predicate device is intended for antegrade insertion. To facilitate this retrograde insertion. the proposed device is packaged in a disassembled form to allow for insertion personnel to assemble the hub assembly once the lumen has been inserted and tunneled back to the insertion site.

In order to facilitate proper connection between the lumen and hub assembly. the hub assembly is outfitted with a stainless steel cannula that is not present in the predicate device. The sure fit of this cannula to lumen, followed by application of the compression ring and hub clamps, is essential to device integrity following the insertion and assembly procedure.

Once inserted and assembled, the principles of operation with regard to hemodialysis are the same as the predicate devices. There are no new questions raised regarding the safety or effectiveness of the device.

Summary of Substantial Equivalence:

In this submission, testing is provided to address the difference in technological characteristics between the proposed and predicate devices. Nonclinical testing and discussion of previously submitted information on the predicate devices establish that there are no new issues of safety or effectiveness for the proposed device.

The proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 876.5540 Blood access device and accessories.

(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.