(164 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of a hemodialysis catheter, with no mention of AI or ML technology.
Yes.
The device is used for hemodialysis, hemoperfusion, or apheresis therapy, which are all therapeutic interventions designed to treat medical conditions by removing harmful substances from the blood or separating blood components.
No
The HemoSplit™ catheter is indicated for use in attaining vascular access for therapies like hemodialysis, hemoperfusion, or apheresis. It is a device for therapeutic access, not for diagnosing conditions.
No
The device description clearly details a physical catheter made of polyurethane with lumens, clamps, and connectors. 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 clearly states the device is for "attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy." These are procedures performed directly on the patient's body to treat conditions, not to diagnose them by examining samples outside the body.
- Device Description: The description details a catheter designed for insertion into veins to facilitate blood flow for treatment. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) outside the body, which is the defining characteristic of an IVD.
Therefore, the HemoSplit™ long-term hemodialysis catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The HemoSplit™ long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein.
Catheters greater than 40 cm are intended for femoral vein insertion."
Product codes
78MSD
Device Description
HemoSplit Long-Term Dialysis Catheters are dual lumen catheters available in straight and precurved configurations with multiple insertion lengths. HemoSplit catheter bodies are made from a polyurethane material that is radiopaque. The dual lumen shaft has a double-D cross-sectional design with a venous lumen tip opening molded to facilitate over-the-guide wire placement. The arterial and venous lumens are separated a maximum of 8cm proximal to the distal tip of the venous lumen, and are able to float freely in the blood stream. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Each extension leg coming out of the bifurcation has an atraumatic acetal occlusion clamp, which closes to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue colorcoded luer connectors identify the arterial and venous lumens, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, external jugular vein, subclavian vein, or femoral vein.
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
Bench testing was performed according to the referenced standards. The test results met the requirements and were compared to the predicate devices. All test results confirm the modified device to be substantially equivalent to the predicate devices.
Key Metrics
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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JUN 1 6 2003
K030020, AI Response HemoSplit
HemoSplit Catheter 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).
General Information:
| Submitter Name: | Bard Access Systems, Inc.
[Wholly owned Subsidiary of C. R. Bard, Inc.] |
|----------------------|----------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ext. 5525 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Glenn Norton |
| Date of Preparation: | April 14, 2003 |
Device Information:
| Device Names: | HemoSplit™ Dual Lumen Catheter |
|---|---|
| Trade Names: | HemoSplit™ |
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78MSD Catheter, Hemodialysis, Implanted |
| 21 CFR 876.5540 (b)(1) - Class III | |
| Implanted Blood Access Device | |
| Classification Panel: | Gastroenterology and Renal |
Class III - No effective date has been established for the requirement for premarket approval for the device described in paragraph (b)(1).
Predicate Devices:
- Opti-Flow (renamed HemoGlide) Long-Term Hemodialysis Catheter, K010567, clearance date � 3/28/2001
- Medcomp Ash Split-Cath II Hemodialysis Catheter, K020465, clearance date 05/22/2002 �
Summary of Change:
The modification to the HemoGlide Long-Term Dialysis Catheter, called HemoSplit, is a redesign of the distal tip configuration in which the lumens are bifurcated at a fixed point of separation, allowing independent movement of the lumens beyond the fixed point. The body of the HemoSplit catheter has the same basic design as HemoGlide with respect to the catheter shaft, bifurcation, and extension legs. However, the catheter shaft material is changed, as arethe new material/design for the luer connector.
Device Description:
HemoSplit Long-Term Dialysis Catheters are dual lumen catheters available in straight and precurved configurations with multiple insertion lengths. HemoSplit catheter bodies are made from a polyurethane material that is radiopaque. The dual lumen shaft has a double-D cross-sectional design with a venous lumen tip opening molded to facilitate over-the-guide wire placement. The arterial and venous lumens are separated a maximum of 8cm proximal to the distal tip of the venous lumen, and are able to float freely in the blood stream. The molded bifurcation has an integral suture wing that is
1
Page 2 of 3
K030020, AI Response HemoSplit
suitable for use with StatLock® securement devices. Each extension leg coming out of the bifurcation has an atraumatic acetal occlusion clamp, which closes to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue colorcoded luer connectors identify the arterial and venous lumens, respectively.
Intended Use of Devices:
The HemoSplit™ long-term hemodialysis catheter is indicated for use in attaining short-term or longterm vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein.
Catheters greater than 40 cm are intended for femoral vein insertion.
Technological Comparison to Predicate Devices:
The technological characteristics of the HemoSplit Dual Lumen Catheter are substantially equivalent to those of the predicate HemoGlide and Ash Split-Cath II catheters in terms of intended use, application, user population, basic design, performance, labeling, packaging, and sterilization method.
510(k) Substantial Equivalence Decision Tree:
New device is compared to Marketed Device?
Yes.
Does the new device have the same indication statement as the predicates?
Yes, with minor modifications.
Does the new device have the same technological characteristics, eg. design, material, etc. ?
Yes. The principles of operation and basic design are a combination of the two predicate devices. The labeling of the Split-Cath II indicates that it is made of Carbothane. The split-tip configuration is fundamentally the same as the Split-Cath II. The dual lumen bifurcated catheter body and extension legs are the same as the HemoGlide. However, the HemoGlide's acetal luer connectors have been replaced with polycarbonate (PC) luer connectors.
Could the new characteristics affect safety or effectiveness?
Yes. The split-tip configuration, the catheter body material change, and material/design change of the connector/bond could affect the safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. Safety and effectiveness questions are the same for all long-term dialysis catheters.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Reliance was placed on recognized standards to evaluate the device's performance. (See Non-Clinical Performance Data below.)
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K030020, Al Response HemoSplit
Are performance data available to assess effects of new characteristics?
Yes. Bench testing was performed according to the referenced standards. The test results met the requirements and were compared to the predicate devices.
Do performance data demonstrate equivalence?
Yes. Performance data demonstrate that the HemoSplit Long-Term Hemodialysis Catheters are substantially equivalent to the predicate HemoGlide Long-Term Hemodialysis Catheters and Ash Split-Cath II Hemodialysis Catheters.
Non-Clinical Performance Data
As this change is being submitted via Abbreviated 510(k), the modification of the HemoGlide catheter was done with conformance to recognized standards:
ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements
ISO 594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings.
In addition, design verification testing was conducted in conformance of FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term Intravascular Catheters, dated 3/16/95, to in-house protocols, and performed or evaluated based on the following FDA Guidance's and recognized standards:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term ● Intravascular Catheters, dated 3/16/95
- ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements ●
- ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters ●
- AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation ● and testing, and the FDA Modified ISO 10993 Test Profile
- AAMI/ANSUISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization
Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long term devices.
All test results confirm the modified device to be substantially equivalent to the predicate devices.
Conclusions:
The HemoSplit Long-Term Dialysis Catheter met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to the predicate Opti-Flow Long-Term Dialysis Catheter, K010567, concurrence date March 28, 2001, and the Medcomp Ash Split-Cath II Hemodialysis Catheter, K020465, clearance date 05/22/2002
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and top, and a stylized symbol on the right. The symbol features three abstract human profiles facing right, stacked one above the other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2003
Mr. Glenn Norton Senior Regulatory Affairs Specialist Bard Access Systems, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Re: K030020
Trade/Device Name: HemoSplit Long-Term Hemodialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: April 14, 2003 Received: April 15, 2003
Dear Mr. Norton:
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 process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. 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.
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.
4
Page 2 - Mr. Glenn Norton
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.
This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/dsma/dsmamain.html
Sincerely yours.
David A. Bozman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
HemoSplit™ Long-Term Catheter
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the HemoSplit™ Long-Term Hemodialysis Catheter is indicated for the following:
"The HemoSplit™ long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein.
Catheters greater than 40 cm are intended for femoral vein insertion."
Signature of 510(k) Submitter:
Printed Name of Submitter:
Glenn Norton
4-14-03
Date:
*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
David A. Segura
Division Sign-Off Office of Device Evaluation
Prescription Use ✓