(233 days)
Not Found
No
The description focuses on the physical design and materials of a hemodialysis catheter, with no mention of AI or ML capabilities. The performance studies are based on standard functional and material testing, not algorithmic performance.
No
The device is a hemodialysis catheter, which is used for accessing the bloodstream for chronic hemodialysis and apheresis. While essential for a therapeutic process (hemodialysis), the catheter itself is a delivery/access device, not a device that directly performs a therapeutic action on the body.
No
This device is a catheter designed for chronic hemodialysis and apheresis, which are treatment procedures, not diagnostic ones. It is used to facilitate blood access for these treatments.
No
The device description clearly states it is a physical catheter made of polyurethane with a retention cuff and luer adapters, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Symetrex Long Term Hemodialysis Catheter is a physical device designed to be inserted into the body for the purpose of hemodialysis and apheresis. It is a catheter, not a test or reagent used on a sample outside the body.
- Intended Use: The intended use is for chronic hemodialysis and apheresis, which are procedures performed directly on the patient's blood within their body.
- Anatomical Site: The device is placed in the femoral area, indicating it is an implanted or inserted device.
The description clearly points to a medical device used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for 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 37cm implant length are indicated for femoral placement.
Product codes
MSD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized representation of a human figure, with three profiles overlapping to symbolize health and human services. The seal is black and white.
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)
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.
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
-
- K123196 Palindrome™ Precision Symmetric Tip Lumen Catheter
4. 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.
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 Term
Hemodialysis
Catheter(Subject Device) | Rex Medical UltraStream
Chronic Hemodialysis
Catheter (Predicate
Device) | Covidien Palindrome
(Predicate Device) |
|--------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------|
| Catheter Type | Implanted Vascular
Access | Implanted Vascular
Access | Implanted Vascular
Access |
| Intended Use | Hemodialysis and
Apheresis | Hemodialysis and
Apheresis | Hemodialysis and
Apheresis |
| Lumen
Configuration | 2 Kidney Shaped Lumens | 2 Kidney Shaped
Arterial Lumens, 1 Round
Venous Lumen | 2 Kidney Shaped
Lumens |
| Catheter O.D. | 15.5 Fr. | 15.5 Fr. | 14.5 Fr. |
| Arterial/Venous
Access Lumens | Yes | Yes | Yes |
| Color Coded
Female Luers | No: Arterial and Venous
Lumens Interchangeable | Yes: Red (Arterial), Blue
(Venous) | Yes: Red (Arterial),
Blue (Venous) |
| Color Coded
Clamp on
Extensions | Yes | No | No |
| Suture Wing on
Cath. Hub | Yes | Yes | Yes |
| Catheter Cuff for
Tissue In-Growth | Yes | Yes | Yes |
| Radiopaque
Catheter Lumen | 20% Barium Sulfate | 20% Barium Sulfate | 20% Barium Sulfate |
| Offset Tip for
Arterial / Venous
Separation | Symmetrical Tip | Stepped Tip | Symmetrical Tip |
| Hub junction for
catheter lumen /
extension tubing | Injection Molded, One
Piece Hub | Injection Molded, One
Piece Hub | Injection Molded,
One Piece Hub |
| Dilator Provided
for Catheter
Insertion | 10-12 Fr. Dilator, 12-14
Fr. Dilator | 16 Fr. Dilator | 12 Fr. Dilator, 14 Fr.
Dilator |
| Tunneling Tool
provided for
Catheter Insertion | Yes | Yes | Yes |
| Injection Sites
supplied with
Catheter | Yes : Qty 2 Latex Free
Injection Sites | Yes : Qty 2 Latex Free
Injection Sites | Yes : Qty 2 Latex
Free Injection Sites |
| Priming Volume
Printed on Female
Luers | Yes: Priming Volume
Printed on I.D. Tag | Yes: Priming Volume
Printed on I.D. Tag | Yes: Priming Volume
Printed on Female Luer |
| Catheter
Identification and
Reference size
printed on
Catheter Hub | Yes: Name of Catheter
Printed on Hub | Yes: Name of Catheter
Printed on Hub | Yes: Name of
Catheter Printed on
Clamp |
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Image /page/5/Picture/0 description: The image shows the logo for Phase One Medical. The word "phase" is in blue, with the "e" stylized as a circle. To the right of "phase" is the word "one" in blue, stacked vertically. Below "phase" is the word "MEDICAL" in gray, with a trademark symbol to the right.
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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