The Medcomp Hemo-Flow Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

Device Description

The Medcomp Hemo-Flow Catheter is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement.

The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the extensions for ease in identification.

AI/ML Overview

The provided text describes the Medcomp Hemo-Flow Catheter and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria or a study design for a specific performance metric with quantitative results. Instead, it generally states that in vitro performance data "demonstrates that this device is substantially equivalent to legally marketed devices."

Given the information provided, I can infer the acceptance criteria are implicitly defined by the performance of the predicate device and relevant industry standards. The "study" described is a comparison demonstrating substantial equivalence through in vitro testing and biocompatibility assessments.

Here's an attempt to structure the information based on your request, with significant limitations due to the level of detail in the original document:

Acceptance Criteria and Performance Data for Medcomp Hemo-Flow Catheter

The Medcomp Hemo-Flow Catheter's acceptance criteria are implicitly based on demonstrating substantial equivalence to its predicate device, the Medcomp Ash Split-Cath (K972207), and compliance with relevant standards for hemodialysis catheters.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric/Target (Inferred)	Reported Device Performance
Mechanical Performance	Tensile Strength (equivalent to predicate/standards)	"demonstrate that this device is substantially equivalent to legally marketed devices"
	Joint Strength (equivalent to predicate/standards)	"demonstrate that this device is substantially equivalent to legally marketed devices"
	Leakage (equivalent to predicate/standards)	"demonstrate that this device is substantially equivalent to legally marketed devices"
Hemodynamic Performance	Recirculation (equivalent to predicate/standards for hemodialysis)	"demonstrate that this device is substantially equivalent to legally marketed devices"
	Flow Performance (equivalent to predicate/standards for hemodialysis)	"demonstrate that this device is substantially equivalent to legally marketed devices"
Biocompatibility	Meet ISO 10993 requirements for permanent contact device	"demonstrates the materials used meet the requirements of ISO 10993 for a permanent contact device."

Note: The document does not provide specific numerical thresholds or target values for these metrics. The acceptance is based on demonstrating "substantial equivalence" to legally marketed devices and compliance with ISO 10993.

2. Sample Size Used for the Test Set and Data Provenance

The document states "In Vitro performance data," indicating laboratory testing.

Sample Size: Not specified.
Data Provenance: In vitro testing, likely conducted in a laboratory setting. No country of origin is specified for the data, nor whether it was retrospective or prospective (as it's in vitro, these terms aren't directly applicable in the same way as clinical data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). The performance data mentioned for the Medcomp Hemo-Flow Catheter is in vitro (tensile strength, leakage, recirculation, flow performance), which relies on standardized testing methods rather than expert consensus on ground truth in the same way clinical studies would.

4. Adjudication Method (for the test set)

N/A. As the performance data is from in vitro testing of mechanical and hemodynamic properties, an adjudication method for establishing ground truth (like 2+1 or 3+1 for expert review) is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on in vitro performance and biocompatibility to demonstrate substantial equivalence, not on human reader performance with or without AI assistance.

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

N/A. This question is relevant for AI/algorithm-based devices. The Medcomp Hemo-Flow Catheter is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For the in vitro performance data (tensile strength, joint strength, leakage, recirculation, and flow performance), the "ground truth" would be established by:

Standardized measurement protocols: Following established test methods and specifications for each performance characteristic.
Predicate device performance: Comparing the results against the known performance characteristics of the legally marketed predicate device (Medcomp Ash Split-Cath) to establish substantial equivalence.
For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993 standards.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is relevant for machine learning or AI models. This device is a physical catheter, and thus, a training set for an algorithm is not applicable.

9. How the Ground Truth for the Training Set was Established

N/A. See point 8.

Summary

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K994105
page 1 of 2

OCT - 3 2001

510(k) SUMMARY

A. Submitter Information:

Submitter:

Contact: Date Prepared:

B. Trade Name: Common Name: Classification: C.F.R. Section:
MEDCOMP® 1499 Delp Drive Harlevsville, PA 19438 (215) 256-4201 Telephone (215) 256-1787 Fax Jeanne M. Cush October 29, 1999

Medcomp Hemo-Flow Catheter Hemodialysis Catheter, Implanted 78 MSD 876.5540

C. Predicate Device:
K972207 Medcomp Ash Split-Cath

D. · Device Description:

E. Intended Use:

The Medcomp Hemo-Flow Catheter in indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

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K994105
page 2 of 2

Comparison to Predicate Device: F.

The technological characteristics of the Hemo-Flow are substantially equivalent to the predicate in terms of intended use, insertion method, anatomical location, design, performance, labeling, manufacturing process and method of sterilization.

The difference between these devices is the material formulation and the Ash Split-Cath lumens are intended to be split prior to insertion.

G. Performance Data:

In Vitro performance data for the Medcomp Hemo-Flow, including tensile strength, joint strength, leakage, recirculation and flow performance demonstrate that this device is substantially equivalent to legally marketed devices intended for hemodialysis and apheresis treatments.

Biocompatibility testing on the Hemo-Flow Catheters demonstrates the materials used meet the requirements of ISO 10993 for a permanent contact device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of an eagle with its wings spread, facing to the right. The eagle is depicted with three lines forming its wings and two curved lines representing its tail feathers.

Public Health Service

OCT - 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanne M. Cush Technical Submissions Coordinator Medical Components. Inc. 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K994105

MedComp® Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36 and HFS-40 Dated: December 6, 1999 Received: December 6, 1999 Regulatory Class: III 21 CFR 8876.5540/Procode: 78 MSD

Dear Ms. Cush:

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 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). 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 equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.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.

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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may

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Page 2 - Ms. Jeanne Cush

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. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K944105
Page 1 of 1

INDICATIONS FOR USE

510(k) Number:

Device Name: Medcomp Hemo-Flow Double Lumen Catheter

Indications for use:

The Medcomp Hemo-Flow Catheter is indicated for use in attaining long-term The Mediomp Homo From Sunieter was and apheresis. It may be inserted percutaneously vaoular a00000 for nomedialy would be vein of an adult patient. Alternate insertion site includes the subclavian vein as required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Divided Signage

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K994105

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter_

(Optional Format 1-2-96)

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.