The Symetrex Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Device Description

The Symetrex Long Term Hemodialysis Catheter is a chronic. 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

AI/ML Overview

This document is a 510(k) Summary for the Symetrex Long Term Hemodialysis Catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner typically associated with clinical trial outcomes or AI/algorithm performance.

Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as it does not describe a study involving an algorithm or human readers.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the device's functional performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparative functional testing and material testing. The performance is reported as meeting these equivalence standards.

Acceptance Criteria Category (Implied by equivalence)	Reported Device Performance
Intended Use Equivalence	The Symetrex Long Term Hemodialysis Catheter has the same intended use (chronic hemodialysis and apheresis) as the predicate devices.
Technological Characteristics Equivalence	Catheter Type: Implanted Vascular Access (Same as predicates)Intended Use: Hemodialysis and Apheresis (Same as predicates)Lumen Configuration: 2 Kidney Shaped Lumens (Different from one predicate with 2 Kidney Shaped Arterial and 1 Round Venous, but deemed equivalent)Catheter O.D.: 15.5 Fr. (Same as one predicate, different from another)Arterial/Venous Access Lumens: Yes (Same as predicates)Color Coded Female Luers: No (Different from predicates, but indicates interchangeability, implying equivalent safety/functionality)Color Coded Clamp on Extensions: Yes (Different from predicates)Suture Wing on Cath. Hub: Yes (Same as predicates)Catheter Cuff for Tissue In-Growth: Yes (Same as predicates)Radiopaque Catheter Lumen: 20% Barium Sulfate (Same as predicates)Offset Tip for Arterial / Venous Separation: Symmetrical Tip (Same as one predicate, different from another with Stepped Tip, but deemed equivalent)Hub junction for catheter lumen / extension tubing: Injection Molded, One Piece Hub (Same as predicates)Dilator Provided for Catheter Insertion: 10-12 Fr. Dilator, 12-14 Fr. Dilator (Different sizes from predicates, but dilators are provided)Tunneling Tool provided for Catheter Insertion: Yes (Same as predicates)Injection Sites supplied with Catheter: Yes : Qty 2 Latex Free Injection Sites (Same as predicates)Priming Volume Printed on Female Luers: Yes: Priming Volume Printed on I.D. Tag (Different location/method than one predicate, but still provided)Catheter Identification and Reference size printed on Catheter Hub: Yes: Name of Catheter Printed on Hub (Different location than one predicate, but still provided)
Safety and Effectiveness Equivalence (Non-Clinical)	Comparative functional testing to predicate devices performed based on ISO 10555-1 and FDA's Draft Guidance. Material testing included ISO 10993 Biocompatibility Testing. The device conforms to special controls mandated by 21 CFR 876.5540. Testing results revealed the subject device to be substantially equivalent to the predicate device, raising no new questions of safety and effectiveness.

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

This information is not provided in the document. The document refers to "comparative functional testing" and "material testing" but does not specify sample sizes or data provenance.

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 as this document does not describe a study involving expert-established ground truth for a diagnostic or AI device. The ground truth for device performance is established through engineering and material testing standards.

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

This information is not applicable as this document does not describe a study involving human readers or adjudication.

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

This information is not applicable. This document describes a medical device (hemodialysis catheter), not an AI system or diagnostic tool that would involve human readers.

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

This information is not applicable. This document describes a medical device (hemodialysis catheter), not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by:

ISO 10555-1 standards: These international standards define requirements for sterile, single-use intravascular catheters. Meeting these standards serves as the "ground truth" for functional performance.
FDA's Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff: This guidance provides the "ground truth" for regulatory expectations and acceptable performance characteristics for such devices.
ISO 10993 Biocompatibility Testing: These standards establish the "ground truth" for material safety and biological compatibility.
21 CFR 876.5540 (Special Controls): This regulation specifies the "ground truth" for mandatory controls for blood access devices.

8. The sample size for the training set

This information is not applicable as this document describes a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this document describes a physical medical device, not an AI model.

Summary

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

November 26, 2014

Phase One Medical % Aditya Sukthankar Official Correspondent MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K140884

Trade/Device Name: Symetrex Long Term Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood Access Devices and Accessories Regulatory Class: II (Special Controls) Product Code: MSD Dated: October 27, 2014 Received: October 29, 2014

Dear Aditya Sukthankar,

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. However, you are responsible to determine that the medical devices you use as components in the kit/trav 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/tray. 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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Herbert P. Lerner -S

for Benjamin 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140884

Device Name Symetrex Long Term Hemodialysis Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K 140884

Submitter's Identification: 1.

Phase One Medical 35 Pond Park Road Hingham. MA 02043 Tel: 781-740-0076 Fax: 781-740-0060 Contact: Mr. Adrian Ravenscroft Engineer

Date Summary Prepared: November 26, 2014

2. Name of the Device:

Symetrex Long Term Hemodialysis Catheter

Device Common Name: Catheter, Hemodialysis, Implanted Device Classification Name: Blood Access device and accessories Product Regulation Number: 21 CFR Part 876.5540 Product Code: MSD Regulatory Class: II (Special Controls) Classification Panel: Gastroenterology and Urology

3. Predicate Devices' Information:

K102043 - Rex Medical UltraStream Chronic Hemodialysis Catheter

1. K123196 Palindrome™ Precision Symmetric Tip Lumen Catheter

4. Device Description:

5. Intended Use:

The Symetrex Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37 cm implant length are indicated for femoral placement.

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6. Comparison to Predicate Devices:

Attribute	Symetrex Long TermHemodialysisCatheter(Subject Device)	Rex Medical UltraStreamChronic HemodialysisCatheter (PredicateDevice)	Covidien Palindrome(Predicate Device)
Catheter Type	Implanted VascularAccess	Implanted VascularAccess	Implanted VascularAccess
Intended Use	Hemodialysis andApheresis	Hemodialysis andApheresis	Hemodialysis andApheresis
LumenConfiguration	2 Kidney Shaped Lumens	2 Kidney ShapedArterial Lumens, 1 RoundVenous Lumen	2 Kidney ShapedLumens
Catheter O.D.	15.5 Fr.	15.5 Fr.	14.5 Fr.
Arterial/VenousAccess Lumens	Yes	Yes	Yes
Color CodedFemale Luers	No: Arterial and VenousLumens Interchangeable	Yes: Red (Arterial), Blue(Venous)	Yes: Red (Arterial),Blue (Venous)
Color CodedClamp onExtensions	Yes	No	No
Suture Wing onCath. Hub	Yes	Yes	Yes
Catheter Cuff forTissue In-Growth	Yes	Yes	Yes
RadiopaqueCatheter Lumen	20% Barium Sulfate	20% Barium Sulfate	20% Barium Sulfate
Offset Tip forArterial / VenousSeparation	Symmetrical Tip	Stepped Tip	Symmetrical Tip
Hub junction forcatheter lumen /extension tubing	Injection Molded, OnePiece Hub	Injection Molded, OnePiece Hub	Injection Molded,One Piece Hub
Dilator Providedfor CatheterInsertion	10-12 Fr. Dilator, 12-14Fr. Dilator	16 Fr. Dilator	12 Fr. Dilator, 14 Fr.Dilator
Tunneling Toolprovided forCatheter Insertion	Yes	Yes	Yes
Injection Sitessupplied withCatheter	Yes : Qty 2 Latex FreeInjection Sites	Yes : Qty 2 Latex FreeInjection Sites	Yes : Qty 2 LatexFree Injection Sites
Priming VolumePrinted on FemaleLuers	Yes: Priming VolumePrinted on I.D. Tag	Yes: Priming VolumePrinted on I.D. Tag	Yes: Priming VolumePrinted on Female Luer
CatheterIdentification andReference sizeprinted onCatheter Hub	Yes: Name of CatheterPrinted on Hub	Yes: Name of CatheterPrinted on Hub	Yes: Name ofCatheter Printed onClamp

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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

Comparative functional testing to the predicated devices was performed based on ISO 10555-1 and the FDA's Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff. Material testing also included ISO 10993 Biocompatibility Testing. Symetrex Long Term Hemodialysis Catheter conforms to the special controls mandated by 21 CFR 876.5540. Testing results revealed the subject device to be substantially equivalent to the predicate device.

8. Discussion of Clinical Tests Performed:

Not applicable as there are no new indications for use which must be supported by clinical data.

9. Conclusions:

The subject device, the Symetrex Long Term Hemodialysis Catheter, has the same intended use as the predicate devices, the Rex Medical UltraStream Chronic Hemodialysis Catheter (K102043) and the Palindrome™ Precision Symmetric Tip Dual Lumen Catheter (K123196). Bench testing and non-clinical testing supplied within our submission demonstrates that there are not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness. Therefore, the Symetrex Long Term Hemodialysis Catheter is substantially equivalent to the predicate devices, the Rex Medical UltraStream Chronic Hemodialysis Catheter (K102043) and the Palindrome™ Precision Symmetric Tip Dual Lumen Catheter (K123196).

PHASE ONE MEDICAL LLC 35 Pond Park Road Suite 13 Hingham MA 02043

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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.