(85 days)
Not Found
No
The summary describes a mechanical repair kit for a dialysis catheter and contains no mention of AI or ML technology.
No
This device is a repair kit for a catheter, not a device that provides therapeutic treatment itself.
No
The device is described as a repair kit for dialysis catheters, replacing broken or damaged components. It does not perform any diagnostic function such as identifying diseases or conditions.
No
The device description explicitly states that the device is a "Dialysis Catheter Repair kit" and its components are made from "Delrin," indicating it is a physical kit with hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to repair a dialysis catheter by replacing damaged components. This is a therapeutic or surgical intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device description confirms its purpose is to repair a catheter. The components are materials used for medical devices, not reagents or instruments for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for the physical repair of a medical device used for dialysis, which is a treatment.
N/A
Intended Use / Indications for Use
The intended use of the Catheter Repair Kit with Replacement Connector is to repair damaged external extension leg or connector on hemodialysis catheters.
To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumen Catheter.
Product codes
NFK
Device Description
The Dialysis Catheter Repair kit is used to perform a repair of an Equistream Long-Term Dual Lumen Catheter, replacing cracked or broken luer-lock connectors, clamps and/or damaged extension legs when a minimum of 4.5 cm of viable extension tubing exists. The repair kit components are made from Delrin.
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)
Verification and validation activities were designed and performed to demonstrate that the subject Catheter Repair Kit with Replacement Connector met predetermined performance specifications. Tests were performed on sterilized, finished devices. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters; March 16, 1995
- ISO 10555-1:1995/Amd 1:1999, Amd 2:2004; Sterile, single-use . intravascular catheters, Part 1. General requirements
- AAMI/ANSI/ISO 10993-1:2003; Biological Evaluation of Medical Devices . Part 1: Evaluation and Testing
- ISO 594-2: 1998: Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment—Part 2: Lock Fittings
- AAMI/ANSI/ISO 11135-1:2007, Sterilization of Health Care Products-. Ethylene Oxide –Part 1: Requirement for the development, Validation and Routine Control of a Sterilization Process for Medical Devices.
The subject Catheter Repair Kit with Replacement Connector met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject Catheter Repair Kit with Replacement Connector configuration and yielded acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Indications for Use
JUL 2 S 2010
510(k) Summary
. . .
Catheter Repair Kit with Replacement Connector
3 May 2010
| General Provisions: | Submitter of 510(k)
Premarket Notification: | Bard Access Systems, Inc. (BAS)
[Subsidiary of C.R. Bard, Inc.]
Salt Lake City, Utah 84116
Phone: (801) 522-5000, Ext. 5567
Fax: (801) 522-5425 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Mark Nelson, Regulatory Affairs |
| | Device Trade Name: | Catheter Repair Kit with Replacement Connector |
| | Device Generic Name: | Catheter Repair Kit |
| Classification: | 21 CFR §876.5540, Class II
NFK- Kit, Repair, Catheter, Hemodialysis
Classification Panel: Gastroenterology and Urology | |
| Predicate Device | Predicate Device Name: | Catheter Repair Kit with Replacement Connector
K063446 |
| Device Description | The Dialysis Catheter Repair kit is used to perform a repair of an Equistream Long-
Term Dual Lumen Catheter, replacing cracked or broken luer-lock connectors, clamps
and/or damaged extension legs when a minimum of 4.5 cm of viable extension tubing
exists. The repair kit components are made from Delrin. | |
| | Figure 1: The two-piece replacement connector
Image: Two-piece replacement connector with labels "Connector" and "Collar" | |
| Device Function | | The replacement connector (Figure 1) is designed to function in the same fashion as
the luer connector it replaced. Dialysis is performed through the catheter by
connecting the dialysis blood lines to the connectors of the dialysis catheter. |
| Intended Use | The intended use of the Catheter Repair Kit with Replacement Connector is to
repair damaged external extension leg or connector on hemodialysis catheters. | |
To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the
following catheters: Equistream Long-Term Dual Lumen Catheter.
الے متحدہ امریکا
تفصیلات
نیش
1
Technological Characteristics
Verification & Validation Activities (Non-clinical Tests)
Technological characteristics between the subject Catheter Repair Kit with Replacement Connector and the predicate device remain identical. There are no changes to design, material, or chemical composition.
Verification and validation activities were designed and performed to demonstrate that the subject Catheter Repair Kit with Replacement Connector met predetermined performance specifications. Tests were performed on sterilized, finished devices. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term � and Long-Term Intravascular Catheters; March 16, 1995
- ISO 10555-1:1995/Amd 1:1999, Amd 2:2004; Sterile, single-use . intravascular catheters, Part 1. General requirements
- AAMI/ANSI/ISO 10993-1:2003; Biological Evaluation of Medical Devices . Part 1: Evaluation and Testing
- ISO 594-2: 1998: Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment—Part 2: Lock Fittings
- AAMI/ANSI/ISO 11135-1:2007, Sterilization of Health Care Products-. Ethylene Oxide –Part 1: Requirement for the development, Validation and Routine Control of a Sterilization Process for Medical Devices.
The subject Catheter Repair Kit with Replacement Connector met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject Catheter Repair Kit with Replacement Connector configuration and yielded acceptable results.
Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2007, Medical Devices -Risk Management for Medical Devices. No new types of safety or efficacy question were identified for the subject Catheter Repair Kit with Replacement Connector.
Comparing the intended use, indications for use, technological characteristics, and Oompainly the intonation are, int Catheter Repair Kit with Replacement Connector met the requirements for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to the current commercially available Catheter Repair Kit with Replacement Connector (K063446).
Summary of Substantial Equivalence
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using only black and white, which gives it a clean and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Marc Nelson Staff Regulatory Affairs C.R. Bard, Inc. Bard Access Systems, Inc. 605 North 5600 West SALT LAKE CITY UT 84116
JUL 2 5 2010
Re: K101261
Trade/Device Name: Catheter Repair Kit with Replacement Connector Regulation Number: 21 CFR 8876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NFK Dated: May 3, 2010 Received: May 5, 2010
Dear Mr. Nelson:
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. 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.
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
3
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bard Access Systems, Inc. Catheter Repair Kit with Replacement Connector Traditional 510(k) Premarket Notification
Section 4 - Indications for Use Statem
Page 9 of 47
JUL 2 9 2010
510(k) Number (if known):
Device Name:
Catheter Repair Kit with Replacement Connector
Indications for Use:
To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumen Catheter.
Prescription Use > (Part 21 CFR §801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR §801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, Radiological Devices 510(k) Number