K Number
K022905
Device Name
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
Date Cleared
2002-12-13

(101 days)

Product Code
Regulation Number
876.5540
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a radiopaque dual lumen polyurethane catheter intended to remove and return blood. The two lumens are designed in a Circle Crescent (Circle "C") configuration. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The lumens are connected to the extensions via a molded 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 identification rings on the clamps for ease in identification. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement. The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is available in varied implantable lengths, with straight or J-Cannula versions.
More Information

K011916 Super C™ (LifeJet™) Hemodialysis/Apheresis Chronic Catheter

Not Found

No
The description focuses on the physical characteristics and performance of a catheter, with no mention of AI or ML capabilities.

No.
The device is a catheter used for hemodialysis, hemoperfusion, or apheresis therapy, supporting these treatments rather than being a therapeutic device itself.

No

Explanation: The device, the LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter, is indicated for "attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy." This describes a therapeutic, rather than a diagnostic, function as it is used for treatment initiation by providing vascular access for blood removal and return.

No

The device description clearly outlines a physical catheter made of polyurethane with lumens, hubs, extensions, and a retention cuff. The performance studies focus on physical properties like tensile strength, pressurization, flow rate, and stiffness. There is no mention of software as a component or the primary function of the device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Device Function: The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a device that is implanted into the body (jugular or subclavian vein) to facilitate the removal and return of blood for therapeutic purposes (hemodialysis, hemoperfusion, or apheresis). It is a direct intervention on the patient's circulatory system, not a device used to analyze specimens outside the body.
  • Intended Use: The intended use clearly states it's for "attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy." This is a therapeutic and access function, not a diagnostic one.

The device description and performance studies further support that this is a medical device used for direct patient treatment, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

Product codes (comma separated list FDA assigned to the subject device)

78 MSD

Device Description

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a radiopaque dual lumen polyurethane catheter intended to remove and return blood. The two lumens are designed in a Circle Crescent (Circle "C") configuration. The distal venous lumen extends beyond the arterial lumen to reduce recirculation.

The lumens are connected to the extensions via a molded 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 identification rings on the clamps for ease in identification. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement.

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is available in varied implantable lengths, with straight or J-Cannula versions.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

jugular or subclavian vein

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

In-vitro performance data for the modified LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter includes:

  • Tensile strenath .
  • Catheter Pressurization/Leak Testing ●
  • . Flow rate
  • Catheter stiffness .

Clinical data was deemed not necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device intended for hemodialysis and apheresis treatments.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011916 Super C™ (LifeJet™) Hemodialysis/Apheresis Chronic Catheter

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

KC22905 Page 1 of 2

510(k) Summary of Safety and Effectiveness LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter

| Date Summary

Was Prepared:August 30, 2002
Submitter's Information:Horizon Medical Products, Inc.
One Horizon Way
Manchester, GA 31816
Telephone Number:(706) 846-3126
Fax Number:
Contact:(706) 846-5303
Scott Moeller, RAC, Director of Quality Assurance and
Regulatory Affairs
DEC 13 2002
Device Trade Name:LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter
Device Common Name:Hemodialysis Catheter, Implanted
Classification:78 MSD
Classification Panel :Gastroenterology/Urology
C.F.R. Section:876.5540
Predicate Device:K011916 Super C™ (LifeJet™) Hemodialysis/Apheresis
Chronic Catheter

Device Description:

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a radiopaque dual lumen polyurethane catheter intended to remove and return blood. The two lumens are designed in a Circle Crescent (Circle "C") configuration. The distal venous lumen extends beyond the arterial lumen to reduce recirculation.

The lumens are connected to the extensions via a molded 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 identification rings on the clamps for ease in identification. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement.

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is available in varied implantable lengths, with straight or J-Cannula versions.

Intended Use:

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

01 ﻟﻤﺴﺘ

1

KO22905

Technological Characteristics:

The technological characteristics of the LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter, including intended use, material type, design, operating principle, performance, and method of sterilization are substantially equivalent to the Super C™ (LifeJet™) Hemodialysis/Apheresis Chronic Catheter.

The LifeJet™ modifications include:

  • Change in catheter material durometer .
  • . Increase in French size
  • Dimensional specifications .

The intended use, fundamental scientific technology, principle operation and basic design remain unchanged.

Performance Data:

In-vitro performance data for the modified LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter includes:

  • Tensile strenath .
  • Catheter Pressurization/Leak Testing ●
  • . Flow rate
  • Catheter stiffness .

Clinical data was deemed not necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device intended for hemodialysis and apheresis treatments.

02 1

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold font. The words are stacked on top of each other. The text is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Moeller, RAC Director of Quality Assurance and Regulatory. Affairs Horizon Medical Products, Inc. One Horizon Way MANCHESTER GA 31816

Re: K022905

Trade/Device Name: LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter; 16F x 36cm, F16-36 Series; 16F x 40cm. F16-40 Series; 16F x 45cm, F16-45 Series; 16F x 36cm Precurved, F16-36CK Series; and 16F x 40cm Precurved, F16-40CK Series Regulation Number: 21 CFR 8876.5540

Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: August 30, 2002 Received: September 3, 2002

Dear Mr. Moeller:

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). 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.

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring three abstract shapes, possibly representing human figures or elements of health and well-being.

3

Page 2 - Mr. Scott Moeller

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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 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, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.

Colin M Pollard

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter

Indications for Use:

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Byrum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KO22905 510(k) Number _

V Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter

(Optional Format 1-2-96)