(449 days)
LifeSite Hemodialysis Access System, Medical Components Inc. Tesio®-Cath Catheter
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No
The document describes a mechanical hemodialysis access system and does not mention any AI or ML components or functionalities.
Yes
The device is described as providing "fully implantable blood access for chronic (long term) hemodialysis" and is intended for patients who would otherwise receive standard hemodialysis catheters, indicating its use in treating a chronic medical condition.
No
Explanation: The device is described as a hemodialysis access system providing fully implantable blood access for chronic hemodialysis, which is a treatment modality, not a diagnostic one.
No
The device description explicitly details hardware components made of silicone, titanium, and stainless steel, which are surgically implanted.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- LifeSite System Function: The LifeSite Hemodialysis Access System is a fully implantable device that provides direct access to the bloodstream for hemodialysis. It is a physical conduit for blood flow during the dialysis process.
- Lack of Specimen Analysis: The description of the LifeSite system focuses on its mechanical function for accessing veins and facilitating blood flow for dialysis. There is no mention of it being used to analyze blood or any other bodily fluid in vitro to diagnose or monitor a condition. The 70% isopropyl alcohol is used for localized cleansing, not for analyzing a specimen.
Therefore, based on the provided information, the LifeSite Hemodialysis Access System is a medical device used for treatment (providing access for hemodialysis), not an in vitro diagnostic device used for analyzing specimens.
N/A
Intended Use / Indications for Use
The LifeSite Hemodialysis Access System provides fully implantable blood access for chronic (long term) hemodialysis. It is intended for use in patients who would otherwise be treated with standard cuffed hemodialysis catheters. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the access site (buttonhole), valve pocket and LifeSite valve.
Product codes (comma separated list FDA assigned to the subject device)
78 MSD
Device Description
The LifeSite Hemodialysis Access System is a dialysis access device comprised of two separate valves and cannulas. One valve/cannula is used as the draw and the other valveleannula is the return. The cannulas are placed in cither the internal or external jugular or subclavian veins. They are manufactured from radiopaque silicone. The cannula ends connect to the valves, which are placed in a subcutancous pocket. The values are manufactured from titanium and stainless steel. When accessed with a 14 gauge, fistula needle the valves internal pinch clamp opens allowing access to the vein via the cannula.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
internal or external jugular or subclavian veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Simulated use testing of the LifeSite Valve was performed to provide information on the "Iffe" of the device to ensure proper functionality over long-term use. LifeSite Valves were tested to 6000 actuations (approximately 38 years of use), using a 14-guage needle. After every 100 actuations leak testing was performed. All valves operated properly and no leaks were observed.
A clinical study was performed to ensure patient safety. Twenty-five of the sixty-seven patients in the alcohol trial were on dialysis using LifeSite for 12 months. This study has patisans on that the LifeSite Hemodialysis Access System, when used in conjunction with 70% isopropyl alcohol, is safe for use in patients who require chronic (long-term) hemodiaylsis and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
LifeSite Hemodialysis Access System, Medical Components Inc. Tesio®-Cath Catheter
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.
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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).
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§ 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
DEC - 4 2003
Summary of Safety and Effectiveness 、11
| Submitter: | Nama Doddi, PhD
Senior VP of R & D
Vasca, Inc.
3 Highwood Drive
Tewksbury, MA 01876
(978) 863-4400 (Phone)
(978) 863-4401 (FAX) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 10, 2002 |
| Device: | LifeSite® Hemodialysis Access System |
| Classification: | Blood Access Device and Accessories - Class III -
21 CFR 876.5540 |
| Predicate Device: | LifeSite Hemodialysis Access System and
Medical Components Inc. Tesio®-Cath Catheter |
| Indications for Use: | The LifeSite Hemodialysis Access System provides fully
implantable blood access for chronic (long term)
hemodialysis. It is intended for use in patients who would
otherwise be treated with standard cuffed hemodialysis
catheters. A 70% isopropyl alcohol solution is used in
conjunction with the LifeSite System for the localized
cleansing of the access site (buttonhole), valve pocket and
LifeSite valve. |
| Proposed Modification: | Modified indications for use to provide long-term,
(chronic) access. |
Device Description:
The LifeSite Hemodialysis Access System is a dialysis access device comprised of two separate valves and cannulas. One valve/cannula is used as the draw and the other valveleannula is the return. The cannulas are placed in cither the internal or external jugular or subclavian veins. They are manufactured from radiopaque silicone. The cannula ends connect to the valves, which are placed in a subcutancous pocket. The values are manufactured from titanium and stainless steel. When accessed with a 14
1
gauge, fistula needle the valves internal pinch clamp opens allowing access to the vein via the cannula.
Smanary of Data:
Simulated use testing of the LifeSite Valve was performed to provide information on the "Iffe" of the device to ensure proper functionality over long-term use. LifeSite Valves were tested to 6000 actuations (approximately 38 years of use), using a 14-guage needle. After every 100 actuations leak testing was performed. All valves operated properly and no leaks were observed.
A clinical study was performed to ensure patient safety. Twenty-five of the sixty-seven patients in the alcohol trial were on dialysis using LifeSite for 12 months. This study has patisans on that the LifeSite Hemodialysis Access System, when used in conjunction with 70% isopropyl alcohol, is safe for use in patients who require chronic (long-term) hemodiaylsis and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEC - 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nama Doddi, Ph.D. Senior Vice President, Research & Development VASCA, Inc. 3 Highwood Drive TEWKSBURY MA 01876
Re: K023023
Trade/Device Name: LifeSite® Hemodialysis Access System, Model LHAS14120 LifeSite® Hemodialysis Cannula Exchange Kit, Model LHCEK0000 LifeSite® Insertion Kit, Model LSSK00120 LifeSite® Hemodialysis Access Cannula, Model LHAC12000 Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: September 4, 2003 Received: September 5, 2003
Dear Dr. Doddi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your finding of substantial equivalence of your device to a legally premarked predication. "The station for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dest of compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphatos as ( notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K023023 |
|---|---|
| Device Name: | LifeSite Hemodialysis Access System |
Indications for Use:
The LifeSite Hemodialysis Access System provides fully implantable blood access for chronic (long term) hemodialysis. It is intended for use in patients who would otherwise be treated with standard cuffed hemodialysis catheters. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the access site (buttonhole), valve pocket and LifeSite valve.
(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 | |
|---|---|
| ---------------------- | ---------------------------------------------------------------- |
| (Division Sign-Off) | Nancy C Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K023023 |