(225 days)
Not Found
No
The description focuses on the physical characteristics and performance testing of a hemodialysis catheter, with no mention of AI or ML.
Yes
The device is designed for hemodialysis access to treat renal failure, making it a therapeutic device.
No
Explanation: The device is a hemodialysis catheter, designed for blood infusion and withdrawal in patients with renal failure. It facilitates treatment and is not used to diagnose a medical condition.
No
The device description clearly details a physical catheter made of silicone with lumens, ports, fittings, and a cuff, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "short or long-term hemodialysis access in the presence of renal failure" and for "blood infusion and withdrawal." This describes a device used in vivo (within the body) for a therapeutic procedure (hemodialysis).
- Device Description: The description details a catheter designed to be placed percutaneously (through the skin) and used for blood flow within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve any such in vitro analysis of specimens.
The device described is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Uldall Double Lumen Hemodialysis Catheter is designed for short or long-term hemodialysis access in the presence of renal failure. Percutaneously placed double lumen catheter is intended for blood infusion and withdrawal. This device and components of the tray are supplied sterile and intended for single-use only.
Product codes
78KOC, 78MSD
Device Description
The Uldall Double Lumen Hemodialysis catheter is a silicone double lumen catheter to be used for blood withdrawal and infusion. The silicone material will be the same the material used for the commercially available Uldall Double Lumen Hemodialysis Catheter. The double lumen construction will allow for blood withdrawal through the distal port and blood infusion through the proximal port. The ports will be separated by cutting away 1 cm of the thin walled lumen. The catheter will have standard Luer lock fittings on the proximal end. Lumen volume information will be printed on the extension tubes of the manifold assembly. Tubing clamps will be placed on the extension tubes. A synthetic fiber cuff will be affixed to the catheter to allow for device fixation.
The Uldall Double Lumen Hemodialysis Catheter, subject of this submission, will be manufactured with double lumen silicone tubing measuring 11.0 Fr. in outside diameter and 18 cm length.
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
Prescription Use (Per 21 CFR 801.109)
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 catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of the following.
- Pull Testing - Cuff Adhesion to Catheter Shaft
- Pull Testing - Fitting/Extension Tube Junction
- Pull Testing - Tunneler
- Lumen Volume
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as hemodialysis catheter.
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.
0
2/12/99
K982333
P. 1/2
Safety and Effectiveness Information
April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235
Date:
July 1, 1998
Device:
Trade Name: Proposed Classification Name: Uldall Double Lumen Hemodialysis Catheter Accessories, Blood Circuit, Hemodialysis (78KOC)
Predicate Devices:
The Uldall Double Lumen Hemodialysis Catheter, subject of this submission, is similar in terms of intended use, materials of construction and technological characteristics to predicate devices.
Device Description:
The Uldall Double Lumen Hemodialysis catheter is a silicone double lumen catheter to be used for blood withdrawal and infusion. The silicone material will be the same the material used for the commercially available Uldall Double Lumen Hemodialysis Catheter. The double lumen construction will allow for blood withdrawal through the distal port and blood infusion through the proximal port. The ports will be separated by cutting away 1 cm of the thin walled lumen. The catheter will have standard Luer lock fittings on the proximal end. Lumen volume information will be printed on the extension tubes of the manifold assembly. Tubing clamps will be placed on the extension tubes. A synthetic fiber cuff will be affixed to the catheter to allow for device fixation.
Substantial Equivalence:
The Uldall Double Lumen Hemodialysis Catheter, subject of this submission, is substantially
રર
1
K982333
p. 2/2
equivalent to the commercially available Uldall Double Lumen Hemodialysis Catheter, D.C.#K923468 and the PermCath Dual Lumen Catheter, D.C.#K871749. The original Uldall Double Lumen Hemodialysis Catheter is being marketed by COOK INCORPORATED today. It is manufactured with double lumen silicone tubing measuring 16.0 Fr. in outside diameter and 26, 28, 30 and 32 cm lengths. The Uldall Double Lumen Hemodialysis Catheter, subject of this submission, will be manufactured with double lumen silicone tubing measuring 11.0 Fr. in outside diameter and 18 cm length.
Test Data
The catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of the following.
- 0 Pull Testing - Cuff Adhesion to Catheter Shaft
- 0 Pull Testing - Fitting/Extension Tube Junction
- 0 Pull Testing - Tunneler
- Lumen Volume
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as hemodialysis catheter.
2
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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Ms. April Lavender, RAC Vice President Regulatory Affairs COOK®. Inc. 925 South Curry Pike P.O. Box 489 Bloomington. Indiana 47402
Re: K982333
Uldall Double Lumen Hemodialysis Catheter (11.0 Fr.) Regulatory Class: III 21 CFR 876.5540/Product Code: 78 MSD Dated: November 13, 1998 Received: November 16, 1998
Dear Ms. Lavender:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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., sterlize) 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, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
3
Page 2 - Ms. April Lavender
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 the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.
J.T.
CAPT. Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _______ of ______________________________________________________________________________________________________________________________________________________________
:
INDICATIONS FOR USE
| 510(k) Number: | K982333 |
|---|---|
| Device Name: | Uldall Double Lumen Hemodialysis Catheter (11.0 Fr.) |
| Indications For Use: | The Uldall Double Lumen Hemodialysis Catheter is designed for short or long-term hemodialysis access in the presence of renal failure. Percutaneously placed double lumen catheter is intended for blood infusion and withdrawal. This device and components of the tray are supplied sterile and intended for single-use only. |
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | --- |
OR
| Over the Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K982333 / S 001 |
|---|---|
| --------------- | ---------------------------- |