(167 days)
Not Found
No
The summary describes a physical medical device (a hemodialysis catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is a hemodialysis catheter, which is used for chronic hemodialysis, a therapeutic procedure that removes waste products from the blood of patients with kidney failure.
No
The device is a hemodialysis catheter, which is a therapeutic device used for chronic hemodialysis and apheresis, not for diagnosis.
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 medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "chronic hemodialysis and apheresis." These are procedures performed directly on the patient's body to filter blood or remove specific components.
- Device Description: The description details a physical catheter designed for insertion into the body ("inserted percutaneously or by cut down," "femoral placement"). It describes its physical characteristics like material, size, and features for anchoring and flow.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of the Symetrex™ catheter does not involve the analysis of specimens in this manner.
The Symetrex™ Long Term Hemodialysis Catheter is a medical device used for a therapeutic procedure performed in vivo (within the living body).
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 aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
Product codes (comma separated list FDA assigned to the subject device)
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 arochr 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Symetrex™ Long Term Hemodialysis Catheter, is equivalent to the predicate device, Symetrex™ Long Term Hemodialysis Catheter (K140884). The performance testing was performed in accordance with the following standards:
ISO 10555-1: Intravascular catheters -- sterile and single-use intravascular catheters -- part 1: general requirements. Performance Testing: Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow.
ISO 11607-1: Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)]. Performance Testing: V-10712: 15.5F Symetrex Catheter - Shipping Tests - 32cm Clamshell Tray w/Packaging Envelope; V-10713: 15.5F Symetrex Catheter - Shipping Test.
ISO 11607-2: Packaging for terminally sterilized medical devices - part 2: validation requirements for forming, sealing and assembly processes [including: amendment 1 (2014)]. Performance Testing: V-10712: 15.5F Symetrex Catheter - Shipping Tests - 32cm Clamshell Tray w/Packaging Envelope; V-10713: 15.5F Symetrex Catheter - Shipping Test.
ISO 594-1: conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - part 1: general requirements. Performance Testing: Gauging.
ISO 594-2: Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - part 2: lock fittings. Performance Testing: Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking.
Recirculation: Symetrex™ Long Term Hemodialysis Catheter has less than 1% recirculation in forward and reverse flow when tested in vitro.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font and is placed within a blue square.
November 16, 2017
Medcomp (DBA Medical Components, Inc.) Courtney Nix Regulatory Affairs Manager, North America and EU 1499 Delp Drive Harleysville, PA 19438
Re: K171618
Trade/Device Name: Symetrex Long Term Hemodialysis Catheter Regulation Number: 21 CFR& 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MSD Dated: October 6, 2017 Received: October 11, 2017
Dear Courtney Nix:
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 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, 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 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.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171618
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 aphersis. 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) |
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3
Image /page/3/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape above the word "medCOMP". The word "med" is in red and the word "COMP" is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Section 6 | | 510(k) SUMMARY
K171618 | Traditional 510K |
|-----------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 1. | Submitter Information: | | |
| | Submitter: | Medical Components Inc.
Dba Medcomp®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201, x 2285
Fax: (215) 256-9191 | |
| | Registration Number: | 2518902 | |
| | Contact: | Courtney Nix
Cnix@Medcompnet.com
Regulatory Affairs Manager: North America and EU | |
| | Date Prepared: | 05/30/2017 | |
| 2. | Proposed or Subject Device Information: | | |
| | Trade Name: | Symetrex™ Long Term Hemodialysis Catheter | |
| | Device: | Catheter, Hemodialysis, Implanted | |
| | Product Code: | MSD | |
| | Regulation Description: | Blood access device and accessories | |
| | C.F.R. Section: | 21 CFR 876.5540 | |
| | Class: | II (Special Controls) | |
| | Regulation Medical Specialty and Review Panel: | Gastroenterology/Urology | |
| 3. | Predicate Device Information: | | |
| | 510(k) Number: | K140884 | |
| | 510(k) Holder: | Medcomp® | |
| | Trade Name: | Symetrex™ Long Term Hemodialysis Catheter | |
| | Device: | Catheter, Hemodialysis, Implanted | |
| | Product Code: | MSD | |
4
Image /page/4/Picture/1 description: The image shows a logo for medCOMP. The logo consists of a red geometric shape above the word "med" in red and "COMP" in black. The geometric shape is an abstract design, possibly representing a stylized letter or symbol.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Regulation Description: | Blood access device and accessories |
|---|---|
| C.F.R Section: | 21 CFR 876.5540 |
| Class: | II (Special Controls) |
| Regulation Medical | |
| Specialty and Review | |
| Panel: | Gastroenterology/Urology |
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 arochr 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. Indications for Use:
The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
6. Intended Use:
Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.
7. Comparison to Predicate Devices:
Symetrex™ Long Term Hemodialysis Catheter is substantially equivalent to the predicate device, Symetrex™ Long Term Hemodialysis Catheter (K140884), in terms of indications for use, intended use, anatomical location, basic design, performance, manufacturing process and method of sterilization.
The difference or changes between the Symetrex™ Long Term Hemodialysis Catheter and the predicate, Symetrex™ Long Term Hemodialysis Catheter (K140884), are the revisions to the labeling (e.g. Instructions for Use), sterilization site, and expanding the componentry.
5
Image /page/5/Picture/1 description: The image shows the logo for medComp. The logo consists of a red geometric shape above the word "med" in red and "COMP" in black. The geometric shape is abstract and appears to be a stylized letter or symbol.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Device | Proposed Device:
Symetrex™ Long Term
Hemodialysis Catheter | Predicate Device:
Symetrex™ Long Term
Hemodialysis Catheter
(K140884) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Symmetric Tip, Dual Kidney
Shaped Lumen Catheter | Symmetric Tip, Dual Kidney
Shape Lumen Catheter |
| Lengths | 19cm-42cm | 19cm-42cm |
| Indications
for Use | The Symetrex™ Long Term
Hemodialysis Catheter is a
symmetric tip dual lumen
catheter designed for
chronic hemodialysis and
aphersis. It may be inserted
percutaneously of by cut
down. Catheters with
greater than 37cm implant
length are indicated for
femoral placement. | The Symetrex™ Long Term
Hemodialysis Catheter is a
symmetric tip dual lumen
catheter designed for
chronic hemodialysis and
aphersis. It may be inserted
percutaneously of by cut
down. Catheters with
greater than 37cm implant
length are indicated for
femoral placement. |
| Catheter
O.D. | 15.5FR | 15.5FR |
| Sterilization
Method | EO Sterilization | EO Sterilization |
| Materials | Hub (Green):
Carbothane w/ 20% BaSO4
Lumen (White):
Carbothane w/ 20% BaSO4
Cuff:
Polyester Felt
Extension (Clear):
Pellethane
Barbed Luer (Green) :
Isoplast
ID Ring (White with red
ink):
ABS
ID Ring (White with blue
ink):
ABS
Clamp (White):
Polypropylene | Hub (Green):
Carbothane w/ 20% BaSO4
Lumen (White):
Carbothane w/ 20% BaSO4
Cuff:
Polyester Felt
Extension (Clear):
Pellethane
Barbed Luer (Green) :
Isoplast
ID Ring (White with red
ink):
ABS
ID Ring (White with blue
ink):
ABS
Clamp (White):
Polypropylene |
| Components | Dilator, Stylet, Tunneler,
Valved Introducer, and
Guidewire | Dilator, Stylet, Valved
Introducer and Tunneler
Guidewire |
Table 6.1: 510(K) Summary: Design Comparison Matrix
6
Image /page/6/Picture/1 description: The image shows a logo with a red geometric shape at the top and the text "medCOMP" at the bottom. The geometric shape is a stylized letter "G" or a house-like structure with an open roof. The word "med" is in red, matching the color of the geometric shape, while "COMP" is in black. The logo appears to be for a company or organization named medCOMP.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Packaging
Systems | Clamshell tray for catheters
under 33cm
Translumbar tray for
catheters for 33 cm and
greater
Clamshell:
One unit gets a snap lid
one unit is sealed into a
header bag
5 Header bags are placed
in a shipping carton
Translumbar tray:
One unit gets a snap lid
One unit is sealed into a
header bag.
5 units are placed into a
shipping carton. | Symetrex Tray (Predicate)
One units gets a snap lid
One unit is sealed in a
pouch
One sealed unit is placed
into an SBS Shelf Box
15 are placed into a
shipping carton | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Performance
Testing | Priming Volume: | Priming Volume: | | |
| | Tip to Cuff
Length | Lumen
Volume | Tip to Cuff
Length | Lumen
Volume |
| | 19cm | 2.1cc | 19cm | 2.1cc |
| | 23cm | 2.3cc | 23cm | 2.3cc |
| | 28cm | 2.5cc | 28cm | 2.5cc |
| | 33cm | 2.6cc | 33cm | 2.6cc |
| | 37cm | 2.8cc | 37cm | 2.8cc |
| | 42cm | 3.2cc | 42cm | 3.2cc |
| | Recirculation:
SymetrexTM Long Term
Hemodialysis Catheter has
less than 1% recirculation in
forward and reverse flow
when tested in vitro | | Recirculation:
SymetrexTM Long Term
Hemodialysis Catheter has
less than 1% recirculation in
forward and reverse flow
when tested in vitro | |
8. Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Symetrex™ Long Term Hemodialysis Catheter, is equivalent to the predicate device, Symetrex™ Long Term Hemodialysis Catheter (K140884). The performance testing was performed in accordance with the following standards:
Table 6.2: Performance Standards
7
Image /page/7/Picture/1 description: The image contains a logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "M" or an abstract design. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters. The "med" portion is in red, while the "COMP" portion is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Standard | Standard Title | Revision/ Date | Performance
Testing |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10555-1 | Intravascular
catheters --
sterile and single-
use
intravascular
catheters -- part
1: general
requirements. | Second Edition
2013-06-15 | Air Leak, Catheter
Leak, Extension-
Hub, Extrusion-
Hub, Gravity Flow |
| ISO 11607-1 | Packaging for
terminally
sterilized medical
devices - part
1: requirements
for materials,
sterile barrier
systems and
packaging
systems
[including:
amendment 1
(2014)]. | First Edition
2006-04-15 | V-10712:
15.5F Symetrex
Catheter - Shipping
Tests - 32cm
Clamshell Tray
w/Packaging
Envelope
V-10713:
15.5F Symetrex
Catheter - Shipping
Test |
| ISO 11607-2 | Packaging for
terminally
sterilized medical
devices - part
2: validation
requirements for
forming, sealing
and assembly
processes
[including:
amendment 1
(2014)]. | First Edition
2006-04-15 | V-10712:
15.5F Symetrex
Catheter - Shipping
Tests - 32cm
Clamshell Tray
w/Packaging
Envelope
V-10713:
15.5F Symetrex
Catheter - Shipping
Test |
| ISO 594-1 | conical fittings
with a 6% (luer)
taper for
syringes, needles
and
certain other
medical
equipment - part
1: general
requirements. | First edition
1986-06-15, | Gauging |
| ISO 594-2 | Conical fittings
with a 6% (luer) | Second Edition
1998-09-01 | Liquid Leakage
Air Leakage |
8
Image /page/8/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "G" or an abstract building. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters, with "med" in red and "COMP" in black.
- 1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Medcomp®: Symetrex™ Long Term Hemodialysis Catheter | ||||
|---|---|---|---|---|
| ----------------------------------------------------- | -- | -- | -- | -- |
| | taper for
syringes, needles
and
certain other
medical
equipment - part
2: lock fittings. | Separation Force
Unscrewing Torque
Ease of Assembly
Resistance to
Overriding
Stress Cracking |
|--|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
9. Biocompatibility:
Biocompatibility was performed for the Symetrex™ Long Term Hemodialysis Catheter per ISO 10993-1 for a blood implant device with prolonged exposure (i.e. > 24 hours