(44 days)
No
The description focuses on the physical design and intended use of a hemodialysis catheter, with no mention of AI or ML capabilities.
Yes.
The device is indicated for therapies such as hemodialysis, hemoperfusion, or apheresis, which are medical treatments designed to address a disease or condition.
No
Explanation: The device is a long-term hemodialysis catheter used for vascular access during therapies like hemodialysis, hemoperfusion, or apheresis. Its function is to provide access for treatment, not to diagnose a condition.
No
The device description clearly outlines physical components like catheters, 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) to facilitate a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter designed for insertion into veins, which 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 HemoGlide®Star series and HemoGlide®Star series XK long-term hemodialysis catheters are medical devices, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemoGlide Star series and HemoGlide Star series XK catheters are recommended for use in attaining short-term or long-term vascular access for hemodialysis, apheresis, and hemoperfusion treatments.
The HemoGlide® Star series and HemoGlide® Star series XK long-term hemodialysis catheters are 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)
MSD
Device Description
HemoGlide Star series and HemoGlide Star series XK are dual lumen long-term hemodialysis catheters. The catheters have a dual lumen, double-D cross-sectional design with a staggered distal tip. The formed venous lumen tip is designed with smooth tapered tip transitions and a guide wire passage/hole to facilitate easy over-the-wire (sheathless) placement. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Individual arterial and venous lumen extension legs 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)
Bench testing was based on the 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 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General . requirements. Amendment 1., ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters, AAMI/ANSI/ISO I 1135:1994, Medical devices – Validation and routine control of ethylene oxide sterilization. The HemoGlide Star series and HemoGlide Star series XK catheters met the predetermined acceptance criteria. Performance data demonstrate that the HemoGlide Star series and HernoGlide Star series XK Long-Term Hemodialysis Catheters are substantially equivalent to the predicate HemoSplit and HemoSplit XK Long-Term Hemodialysis Catheters.
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.
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.
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K051748 page 1 of 3
AUG 1 2 2005
HemoGlide® Star series HemoGlide® Star series XK
Section 6
HemoGlide® Star Series and HemoGlide® Star Series XK Long-Term Hemodialysis Catheters 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a)
General Information
| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|---|---|
| [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. 5541 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Michaela Rivkowich |
| Date of Preparation: | June 27, 2005 |
| Registration Number: | 1720496 |
| Additional Registration Numbers: | |
| C.R. Bard: | 2212754 |
Subject Device Information
| Device Name: | HemoGlide® Star series Long-Term Hemodialysis Catheter
HemoGlide® Star series XK Long-Term Hemodialysis Catheter |
|-----------------------|---------------------------------------------------------------------------------------------------------------------|
| Trade Name: | HemoGlide® Star series, HemoGlide® Star series XK |
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78 MSD - Catheter, Hemodialysis, Implanted
21 CFR 876.5540(b)(1) - Class III
Blood Access Device |
| Classification Panel: | Gastroenterology and Renal |
Predicate Device Information
| Device Name: | HemoSplit® Long-Term Hemodialysis Catheter |
|---|---|
| Trade Name: | HemoSplit® |
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78 MSD - Catheter, Hemodialysis, Implanted |
| 21 CFR 876.5540(b)(1) - Class III | |
| Blood Access Device | |
| Classification Panel: | Gastroenterology and Renal |
| Device Name: | HemoSplit® XK Long-Term Hemodialysis Catheter |
| Trade Name: | HemoSplit® XK |
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78 MSD - Catheter, Hemodialysis, Implanted |
| 21 CFR 876.5540(b)(1) – Class III | |
| Blood Access Device |
| Predicate Device Name | 510(k) | Clearance Date |
|---|---|---|
| HemoSplit Long-Term Hemodialysis Catheter | K030020 | 6/16/2003 |
| HemoSplit XK Long-Term Hemodialysis Catheter | K033294 | 11/26/2003 |
Image /page/0/Picture/12 description: The image shows the number 000038 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
1
HemoGlide® Star series HemoGlide® Star series XK
Summary of Changes
The predicate HemoSplit XK catheters have been successfully received by the clinicians. The HemoGlide Star series/HemoGlide Star series XK catheters are modifications of the HemoSplit and HemoSplit XK catheters. The main difference between the devices lies in the design of the distal lumen tips. The predicate HemoSplit XK catheters are designed with a split-tip configuration whereas the subject HemoGlide Star series /HemoGlide Star series XK catheters incorporate a fixed, staggered lument tip. A staggered lumen tip design has precedence in the market for long-term dialysis catheters: for example, BAS Opti-Flow long-term dialysis catheters with a staggered distal lumen tip design were cleared in K010567.
This 510(k) also includes the addition of depth markings on the catheter shaft tubing and minor changes in labeling that correspond to the modified design.
Device Description
HemoGlide Star series and HemoGlide Star series XK are dual lumen long-term hemodialysis catheters. The catheters have a dual lumen, double-D cross-sectional design with a staggered distal tip. The formed venous lumen tip is designed with smooth tapered tip transitions and a guide wire passage/hole to facilitate easy over-the-wire (sheathless) placement. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Individual arterial and venous lumen extension legs 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.
Intended Use
HemoGlide Star series and HemoGlide Star series XK catheters are recommended for use in attaining short-term or long-term vascular access for hemodialysis, apheresis, and hemoperfusion treatments.
Indications for Use
The HemoGlide® Star series and HemoGlide® Star series XK long-term hemodialysis catheters are 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.
Technological Comparison to Predicate Devices
The technological characteristics of the HemoGlide Star series and HemoGlide Star series XK catheters are substantially equivalent to those of the predicate HemoSplit XK 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.
2
KOS'7-48 m3x343
HemoCilide Star series HemoGlide® Star scries XK
Does the new device have the same indication statement and intended use as the predicate?
Yes.
Does the new device have the same technological characteristics, e.g. design, material, ctc.?
Not in all regards. The principles of operation and basic design are the same as the predicate devices. The changes in design comprise of the addition of depth markings and of a modified staggered distal tip instead of a split distal tip. There is precedence in the market for a staggered tip catheter.
Could the new characteristics affect safety or effectiveness?
Yes. The design changes may affect 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. Testing was based on FDA guidance document and recognized standards to evaluate the devices' performance:
- 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 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General . requirements. Amendment 1.
- ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
- . AAMI/ANSI/ISO I 1135:1994, Medical devices – Validation and routine control of ethylene oxide sterilization
Are performance data available to assess effects of new characteristics?
Yes. Bench testing was based on the above referenced guidance document and standards and the HemoGlide Star series and HemoGlide Star series XK catheters met the predetermined acceptance criteria.
Do performance data demonstrate equivalence?
Yes. Performance data demonstrate that the HemoGlide Star series and HernoGlide Star series XK Long-Term Hemodialysis Catheters are substantially equivalent to the predicate HemoSplit and HemoSplit XK Long-Term Hemodialysis Catheters.
Conclusion
The HemoGlide Star series and HemoGlide Star series XK Long-Term Hemodialysis Catheters met all predetermined performance acceptance and validation requirements as specified by test protocols and/or user needs and are substantially equivalent to the predicate HemoSplit Long-Term Hemodialysis Catheter, K030020, and the HemoSplit XK Long-Term Hemodialysis Catheter, K033294.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid with three parallel lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2005
Ms. Michaela Rivkowich Sr. Regulatory Affairs Specialist Bard Access Systems, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Re: K051748
Trade/Device Name: HemoGlide® Star series Long-Term Hemodialysis Catheter, HemoGlide® Star series XK Long-Term Hemodialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: August 9, 2005 Received: August 10, 2005
Dear Ms. Rivkowich:
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.
4
Page 2 - Ms. Michaela Rivkowich
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 (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 (OS) 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
David A. Deyson
for
N
I
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KOSI748 passe loft
HemoGlide® Star series HemoGlide® Star series XK
Section 1.2
Indications for Use
510(k) Number (if known): K05) 748
Device Name: HemoGlide® Star series Long-Term Hemodialysis Catheter, HemoGlide® Star series XK Long-Term Hemodialysis Catheter
Indications for Use:
The HemoGlide®Star scries and HemoGlide®Star series XK long-term hemodialysis catheters are 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.
Prescription Use x (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number .