(21 days)
Catheter Repair Kit with Replacement Connector, K011015
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts in the provided text.
No.
The device is a repair kit for existing catheters, acting as a replacement part rather than providing a therapeutic effect itself.
No.
The device is a catheter repair kit, which is used to replace connectors or repair damaged extension tubing of existing catheters. Its intended use describes repair and replacement, not diagnosis of any medical condition.
No
The device description and intended use clearly indicate a physical repair kit for catheters, not a software application.
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 or replace damaged components of specific types of catheters used for vascular access. This is a direct medical intervention on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "Catheter Repair Kit with Replacement Connector," which aligns with the intended use of repairing physical medical devices.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, providing diagnostic information, or any other activity typically associated with in vitro diagnostics.
In summary, this device is a medical device intended for the repair of other medical devices used in patient care, not for diagnostic testing performed outside the body.
N/A
Intended Use / Indications for Use
To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Tern Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.
Product codes
78 NFK
Device Description
The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Catheter Repair Kit with Replacement Connector, K011015
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.
0
AUG 2 3 2002
Section 5
Catheter Repair Kit with Replacement Connector
510(k) Summary of Safety and Effectiveness Information 21 CFR 807.92
1. Submitter Information:
Submitter Name:
Address:
Telephone Number: Fax Number: Contact Person: Date of Preparation:
Bard Access Systems, Inc. [Subsidiary of C. R. Bard, Inc.] 5425 W. Amelia Earhart Drive Salt Lake City, UT 84116 (801) 595-0700, Ext. 4903 (801) 595 5425 Peggy Keiffer
Device Name: 2.
Catheter Repair Kit with Replacement Connector Device Name: Trade Name: Catheter Repair Kit Common/Usual Name: Catheter Repair Kit MSD Blood Access Device Accessory Classification Name: 21 CFR 876.5540 Class II
Classification Panel:
3. Predicate Device Name:
| Device Name: | Catheter Repair Kit with Replacement Connector |
|---|---|
| Trade Name: | Catheter Repair Kit |
| Common/Usual Name: | Catheter Repair Kit |
| Classification Name: | MSD Blood Access Device Accessory |
| 21 CFR 876.5540, Class II | |
| Classification Panel: | Gastroenterology and Renal |
4. Device Description
The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.
Gastroenterology and Renal
5. Intended Use
To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters:
- Soft-Cell® Long-Term Dual Lumen Catheter
- . Opti-Flow® Long-Term Dual Lumen Catheter
- Slim-Cath™ Short-Term Dual Lumen Catheter .
- Vaccess® Short-Term Single Lumen Catheter .
- Flexxicon® Short-Term Dual Lumen Catheter ●
- Niagara™ Short-Term Dual Lumen Catheter .
- Flexxicon® II Short-Term Dual Lumen Catheter .
- HemoGlide™ Long-Term Dual Lumen Catheter .
1
Image /page/1/Picture/0 description: The image shows the text "K022561 Page 2 of 2 Repair Kit 510(k)". The text appears to be part of a document or label. The phrase "Page 2 of 2" indicates that this is the second page of a two-page document. The term "Repair Kit" suggests that the document is related to a repair kit, and "510(k)" likely refers to a regulatory submission or approval process.
-
- Technological Characteristics Summary:
6.1 Does the new device have the same indication statement?
No. The HemoGlide™ Long-Term Dual Lumen catheter is added to the list of repairable catheters in the indication for use and the description of temporary catheter was changed to short-term for labeling consistency.
-
Do the differences alter the intended therapeutic/diagnostic/etc. effect? Deciding may 6.2 consider impact on safety and effectiveness.
No, the intended use is the same. There is only the addition of a catheter trade name added to the list of repairable catheters and a change of the description of temporary catheter to short-term for labeling consistency. -
6.3 The new device has the same intended use and may be "Substantially Equivalent."
Yes, the intended use is identical. -
6.4 Does the new device have the same technological characteristics, e.g. design, materials, etc.?
Yes, the technological characteristics are exactly the same. -
6.5 Are the descriptive characteristics precise enough to ensure equivalence?
Yes.
Conclusion:
Based on FDA's decision tree, the Catheter Repair Kit with Replacement Connector is substantially equivalent to the predicate device, Catheter Repair Kit with Replacement Connector, K011015, concurrence date June 22, 2001.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2002
Re: K022561 ·
Ms. Peggy Keiffer Senior Regulatory Affairs Manager Bard Access Systems, Inc. C. R. Bard, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Trade/Device Name: Catheter Repair Kit with Replacement Connector, Model #5587000 Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 NFK Dated: July 31, 2002 Received: August 2, 2002
Dear Ms. Keiffer:
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.
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); 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.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy Crozdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section I-D .
Catheter Repair Kit with Replacement Connector
510(k)
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Manager of Bard Access Systems, that this notification [510(k)] for the following devices. Catheter Repair Kits with Replacement Connectors, are indicated for the following:
To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Tern Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.
Signature of 510(k) Submitter:
Printed Name of Submitter:
Peggy Keiffer
Date: 7.16.02
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
510(k) Number
Division Sign-Off
Office of Device Evaluation
R022561
Nancy C Brogdon
Prescription Use
OR
Over-The-Counter Use