(43 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its intended use and design. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML. The performance studies described are bench tests comparing the device to a predicate, not studies evaluating algorithmic performance.
Yes
The device is used for hemodialysis, hemoperfusion, or apheresis therapy, which are all therapeutic interventions designed to treat medical conditions.
No
The provided text explicitly states that the device is a "catheter" used for "attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy." It describes the physical characteristics of the catheter and its use in therapeutic procedures, not in diagnosing conditions.
No
The device description clearly details a physical catheter with lumens, tips, clamps, and connectors, indicating 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 is for "attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy." This describes a device used in vivo (within the body) for therapeutic purposes, not for examining specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a catheter designed for insertion into veins to facilitate blood flow for dialysis or similar procedures. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the HemoSplit™ XK long-term hemodialysis catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The HemoSplit™ XK 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 (comma separated list FDA assigned to the subject device)
78MSD
Device Description
HemoSplit XK Long-Term Dialysis Catheters are dual lumen catheters available in straight configurations with multiple insertion lengths. The HemoSplit XK has a dual lumen, double-D crosssectional 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. Individual arterial and venous lumen extension leg have an atraumatic occlusion clamp, which closes the access to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue color-coded 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification of the modification of the HemoSplit catheter was done with conformance to inhouse protocols, and performed or evaluated based on the following FDA Guidance 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/ANSI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization
All test results confirm the modified device to be substantially equivalent to the predicate device.
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.
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
K033 294
NOV 26 2003
HemoSplit XK Catheter Special 510(k)
HemoSplit XK 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: | October 13, 2003 |
Device Information:
| Device Names: | HemoSplit™ XK Dual Lumen Catheter |
|---|---|
| Trade Names: | HemoSplit™ XK |
| 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 Device:
HemoSplit Long-Term Hemodialysis Catheter, K030020, clearance date 6/16/03
Summary of Change:
The modification to the HemoSplit Long-Term Dialysis Catheter is an increase in outer diameter to allow for greater flow at lower pressures. All other aspects of the device, HemoSplit XK, remain the same as the predicate, HemoSplit.
Device Description:
HemoSplit XK Long-Term Dialysis Catheters are dual lumen catheters available in straight configurations with multiple insertion lengths. The HemoSplit XK has a dual lumen, double-D crosssectional 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. Individual arterial and venous lumen extension leg have an atraumatic occlusion clamp, which closes the access to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue color-coded luer connectors identify the arterial and venous lumens, respectively.
1
Page 2 of 3
HemoSplit XK Catheter Special 510(k)
Intended Use of Device:
HemoSplit XK is recommended for use in attaining short-term or long-term vascular access for hemodialysis, apheresis, and hemoperfusion treatments.
Technological Comparison to Predicate Device:
The technological characteristics of the HemoSplit XK Dual Lumen Catheter are substantially equivalent to those of the predicate HemoSplit catheter 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. HemoSplit.
Does the new device have the same indication statement as the predicates?
Yes.
Does the new device have the same technological characteristics, eg. design, material, etc.?
Yes. The principles of operation and basic design are the same. Only the outer diameter is changed from 14.5Fr to 16Fr.
Could the new characteristics affect safety or effectiveness?
Yes. The clinician should use medical judgement to determine when placing a larger size catheter is appropriate for the patient.
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 FDA guidance and recognized standards to evaluate the device's performance.
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 device.
Do performance data demonstrate equivalence?
Yes. Performance data demonstrate that the HemoSplit XK Long-Term Hemodialysis Catheters are substantially equivalent to the predicate HemoSplit Long-Term Hemodialysis Catheters.
2
Page 3 of 3
HemoSplit XK Catheter Special 510(k)
Non-Clinical Performance Data
Design verification of the modification of the HemoSplit catheter was done with conformance to inhouse protocols, and performed or evaluated based on the following FDA Guidance 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/ANSI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization
All test results confirm the modified device to be substantially equivalent to the predicate device.
Conclusions:
The HemoSplit XK Long-Term Dialysis Catheter met all the pre-determined performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to the predicate HemoSplit Long-Term Dialysis Catheter, K030020, concurrence date June 16, 2003.
3
Image /page/3/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2003
Mr. Glen Norton Senior Regulatory Affairs Specialist Bard Access System, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Re: K033294
Trade/Device Name: HemoSplit™ XK 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: November 17, 2003 Received: November 18, 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 (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., 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, and 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
4
Page 2 - Mr. Norton
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 (21 CFR Part 807); 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 the 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Oswald h. Syram
for Na
Di
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
HemoSplit XK Catheter Special 510(k)
Section 1-B
HemoSplit™ XK Long-Term Catheter Special 510(k)
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™ XK Long-Term Hemodialysis Catheter is indicated for the following:
"The HemoSplit™ XK 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
Date:
10.13.03
*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
Prescription Use
(Division Sign-Off) Division of Reproductive. Abdor and Radiological D 510(k) Numbe
ORAL SURGERY ASSOCIATES