(107 days)
Not Found
No
The summary describes a physical medical device (catheter) and its performance characteristics based on standard testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is utilized for therapies like hemodialysis, hemoperfusion, or apheresis therapy.
No
Explanation: The device is a catheter used for temporary or long-term vascular access for therapies like hemodialysis, hemoperfusion, or apheresis. It is a medical device for treatment and access, not for diagnosing conditions or diseases.
No
The device description clearly outlines a physical catheter made of silicone with various lengths, lumens, hubs, and clamps. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for accessing the bloodstream for procedures like hemodialysis, hemoperfusion, or apheresis. These are therapeutic procedures performed directly on the patient's body.
- Device Description: The description details a physical catheter designed for insertion into a vein.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for direct patient treatment.
N/A
Intended Use / Indications for Use
Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative insertion sites include subclavian vein as required.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
- 12.5French double lumen design with cuff for long-term implant.
- Variety of lumen lengths: 15cm, 18cm, 24cm, 32cm, 32cm and 40cm.
- 12.5F with a pre-curved lumen in a 28cm and 32cm length.
- Radiopaque silicone material
- Lumen is connected to the extension via a soft pliable hub with a suture winq .
- Red and blue clamps and red and blue luers are provided on the extension tube to ● prevent air/fluid communications
- . The hub contains the device name and French size, clamp I.D. Rings are printed with the priming volume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein
Indicated Patient Age Range
adult patient
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)
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the Hemo-Cath were previously cleared for similar applications by Medcomp, Inc.
Performance testing of the Hemo-Cath was conducted in accordance with the following international standards:
- ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General Reguirements
- ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous Catheters
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings
Subject product testing has yielded acceptable safety and performance outcomes.
Testing performed: Air Leakage Liquid Leakage Priming Volume Flow verse Pressure Force at Break Recirculation Chemical Exposure Accelerated Aging Mechanical Hemolysis
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the Split Cath® III is substantially equivalent to the cited predicate devices.
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.
K893439, K091953, K981125, K030270, K010306
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
K113487 Page 1 of 2
MAR - 9 2012
510(k) Summarv
Hemo-Cath® Summary of Safety and Effectiveness Prepared November 22, 2011
| Attachment 8
| General Information | |
|---|---|
| Submitter: | MEDCOMP® |
| 1499 Delp Drive | |
| Harleysville, PA 19438 | |
| Phone: (215) 256-4201 | |
| Fax: (215) 256-9191 | |
| Contact: | Jean Callow |
| Regulatory Specialist | |
| Device Trade Name: | Hemo-Cath® |
| Common Name: | Hemodialysis Catheter, Implanted |
| Classification Name: | MSD - Blood access device and accessories |
| CFR Reference: | 21 CFG 876.5540, Class III |
| Classification Panel: | Gastroenterology / Urology |
Predicate Devices:
Device Trade Name: Common Name: Classification Name: CFR Reference: Classification Panel: Premarket Notification: Hemo-Cath® Hemodialysis Catheter, Implanted LJF -Blood access device and accessories 21 CFR 876.5540, Class III Gastroenterology / Urology K893439, concurrence date June 13, 1989 K091953, concurrence date September 16, 2009 K981125, concurrence date February 26, 1999 K030270, concurrence date April 14, 2003 K010306, concurrence date October 3, 2001
Performance Standards: Performance standards have not been established by FDA under section 514 of the Federal Food, Drug, and Cosmetic Act.
Indications for Use:
Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative insertion sites include subclavian vein as required.
Device Description:
Medcomp Hemo-Cath® 510(k) Summary
1
K113487. Pge 2 of 2
- 12.5French double lumen design with cuff for long-term implant.
- Variety of lumen lengths: 15cm, 18cm, 24cm, 32cm, 32cm and 40cm.
- 12.5F with a pre-curved lumen in a 28cm and 32cm length.
- Radiopaque silicone material
- Lumen is connected to the extension via a soft pliable hub with a suture winq .
- Red and blue clamps and red and blue luers are provided on the extension tube to ● prevent air/fluid communications
- . The hub contains the device name and French size, clamp I.D. Rings are printed with the priming volume.
Safety and Performance Tests
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the Hemo-Cath were previously cleared for similar applications by Medcomp, Inc.
Performance testing of the Hemo-Cath was conducted in accordance with the following international standards:
- ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General . Reguirements
- ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and . Certain Other Medical Equipment - Part 2: Lock Fittings
Subject product testing has yielded acceptable safety and performance outcomes.
Testing performed: Air Leakage Liquid Leakage Priming Volume Flow verse Pressure Force at Break Recirculation Chemical Exposure Accelerated Aging Mechanical Hemolysis
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the Split Cath® III is substantially equivalent to the cited predicate devices.
Summary of Substantial Equivalence
Based on the indications for use and safety and performance testing, the Hemo-Cath meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilizations for use to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, overlaid on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Jean Callow Regulatory Specialist MEDCOMP (MEDICAL COMPONENTS) 1499 Delp Drive HARLEYSVILLE PA 19438
MAR - 9 2012
Re: K113487
Trade/Device Name: Hemo-Cath® Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: February 7, 2012 Received: February 8, 2012
Dear Ms. Callow:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 the kit nave thing 100(k) of the act), or were on the market prior to May 28, 1976, the enactment date process (Occiten >>