(90 days)
Not Found
No
The summary describes a mechanical hemodialysis access system and does not mention any AI or ML components or functions.
Yes
The device provides fully-implantable blood access for patients requiring hemodialysis, which is a medical treatment.
No
The device is a hemodialysis access system providing fully-implantable blood access for patients. Its function is to facilitate drug delivery rather than to diagnose a condition.
No
The device description clearly outlines physical components (cannula, valve, tunneler, introducer, needle) that are surgically implanted or used in conjunction with the implanted components. This is a hardware-based 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 to provide fully-implantable blood access for hemodialysis. This is a therapeutic and access device, not a diagnostic one.
- Device Description: The device is described as a system for vascular access, involving a cannula and a valve surgically implanted in the body. This is consistent with a medical device for treatment/access, not for analyzing samples outside the body.
- Lack of Diagnostic Activities: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Accessories: The accessories mentioned (tunneler, introducer, needle) are all related to the implantation and access of the device for blood flow, not for diagnostic testing.
- Performance Studies: The performance studies focus on the physical and clinical performance of the device for vascular access and hemodialysis, not on the accuracy or reliability of diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LifeSite® Hemodialysis Access System provides fully-implantable blood access for patients who require hemodialysis while waiting for creation and/or maturation of permanent access. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the injection site, valve pocket, and LifeSite valve.
Product codes
78 MSD
Device Description
The LifeSite Hemodialysis Access System consists of two primary components: (1) the LifeSite Hemodialysis Access Cannula, and (2) the LifeSite Hemodialysis Access Valve. The valve is surgically placed in a subcutaneous pocket. The cannula, placed into an internal jugular or subclavian vein, is connected to the valve by means of the barbed connector on the valve stem. Vascular access can be achieved by accessing the valve with a needle.
Accessories to the LifeSite Hemodialysis Access System, including a tunneler, introducer and Medisystems needle, will be packaged with the system and sold as a unit. Another accessory, the LifeSite Hemodialysis Cannula Exchange Kit will be sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Internal jugular or subclavian 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)
The LifeSite System was tested for safety and effectiveness. In Vitro tests were chosen and developed based on the October, 1990 FDA document "Guidance on 510(k) Submissions for Implanted Infusion Ports" and Parts 1 and 3 of the international standard ISO10555, "Sterile, single-use, intravascular catheters." Where appropriate, comparative testing was done using the Tesio-Cath device or a BardPort device; the devices used for comparison were chosen based on the presence of predicate design features relevant to the test.
In addition, a prospective, randomized, multi-center clinical trial comparing efficacy of the Vasca LifeSite Hemodialysis Access System (as used with the cleansing solution, Clorpactin) to that of the Medcomp Tesio-Cath device was conducted. Clinical safety and efficacy data on the LifeSite System using isopropyl alcohol as the cleansing solution was obtained in the continued access phase of the multi-center clinical trial and compared to that of the Tesio-Cath.
The performance of the LifeSite System was found to meet all clinically relevant acceptance criteria and was therefore acceptable. Where comparative testing was conducted, the LifeSite System performance was equivalent to or better than that of the relevant predicate performance was acceptable based on clinically relevant criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
AUG 2 4 2000
K001633
PAGE 1 OF 4
VASCA
3 Highwood Drive Tewksbury, MA 01876 Tel: (978) 863-4400 Fax: (978) 863-4401 www.vasca.com
510(k) SUMMARY FOR THE VASCA LIFESITE® HEMODIALYSIS ACCESS SYSTEM
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.
- A. Submitter's Information
| Name: | Vasca, Inc. |
|---|---|
| Address: | 3 Highwood Drive, Tewksbury, MA 01876 |
| Phone: | (978) 863-4400 |
| Fax: | (978) 863-4401 |
| Contact Person: | Douglas E. Ferguson, Regulatory Affairs Manager |
| Date of Preparation: | May 25, 2000 |
B. Device Name:
Trade Name: Common/Usual Name: Classification Name:
LifeSite Hemodialysis Access System Blood Access Device and Accessories Blood Access Device and Accessories
- C. Predicate Device Name(s):
Medcomp Tesio-Cath hemodialysis catheter, K821684 Bard Access Systems BardPort Titanium Implanted Port, K913235
D. Device Description/Indications for Use:
Description
The LifeSite Hemodialysis Access System consists of two primary components: (1) the LifeSite Hemodialysis Access Cannula, and (2) the LifeSite Hemodialysis Access Valve. The valve is surgically placed in a subcutaneous pocket. The cannula, placed into an internal jugular or subclavian vein, is connected to the valve by means of the barbed connector on the valve stem. Vascular access can be achieved by accessing the valve with a needle.
Accessories to the LifeSite Hemodialysis Access System, including a tunneler, introducer and Medisystems needle, will be packaged with the system and sold as a unit. Another accessory, the LifeSite Hemodialysis Cannula Exchange Kit will be sold separately.
1
Indications:
The LifeSite® Hemodialysis Access System provides fully-implantable blood access for patients who require hemodialysis while waiting for creation and/or maturation of permanent access. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the injection site, valve pocket, and LifeSite valve.
Technological Characteristics/Performance Data Summary E.
The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (CDRH 510(k) Manual 92-4158) was utilized in conjunction with the technological characteristics and performance testing results to make a determination of substantial equivalence as follows:
1. Does New Device Have Same Indication Statements?
No. While there are some differences in their specific indication statements, the LifeSite System and Tesio-Cath device have the same intended use. Both devices are intended for blood access for hemodialysis. The LifeSite System has a more narrow indication. The BardPort device also has the same intended use, for blood access. However, the BardPort device has the more specific indication of use for blood sampling and drug administration.
2. Do the Differences Alter the Intended Therapeutic/Diagnostic/etc. Effect ?
No. As stated previously, all three devices are intended to be used for blood access. In addition, both the LifeSite System and Tesio-Cath device are intended to be used for hemodialysis.
3. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?
No. Although there are some similarities, there are several technological characteristics which are different. For example, the mechanism to prevent blood flow when not in use is different for each device. There are also differences in physical dimensions.
2
4. Could the New Characteristics Affect Safety or Effectiveness?
::.
Yes. Changes to the mechanism to prevent blood flow could affect the ability of the device to prevent a leak. Physical changes may affect flow rate and other basic mechanical properties of the device, such as connection strength.
5. Do the New Characteristics Raise New Types of Safety or Effectiveness Questions?
No. The types of safety and effectiveness questions remain the same. Ability to prevent leaks, provide adequate flow rates, and maintain high connection strength between the cannula and valve (for valve/port type devices) are safety and effectiveness concerns common to all blood access devices.
6. Do Accepted Scientific Methods Exist for Assessing Effects of the New Characteristics?
Yes. The International Standards Organization has developed testing methods for assessing intravascular catheters and central venous catheters. The FDA has a guidance document outlining the testing to evaluate implanted infusion ports. These documents provide standard scientific methods for assessing the effects of the new characteristics on the device performance issues noted above.
7. Are Performance Data Available to Assess Equivalence?
Yes. The LifeSite System was tested for safety and effectiveness. In Vitro tests were chosen and developed based on the October, 1990 FDA document "Guidance on 510(k) Submissions for Implanted Infusion Ports" and Parts 1 and 3 of the international standard ISO10555, "Sterile, single-use, intravascular catheters." Where appropriate, comparative testing was done using the Tesio-Cath device or a BardPort device; the devices used for comparison were chosen based on the presence of predicate design features relevant to the test.
In addition, a prospective, randomized, multi-center clinical trial comparing efficacy of the Vasca LifeSite Hemodialysis Access System (as used with the cleansing solution, Clorpactin) to that of the Medcomp Tesio-Cath device was conducted. Clinical safety and efficacy data on the LifeSite System using isopropyl alcohol as the cleansing solution was
LifeSite Hemodialysis Access System 510(k) Submission
3
Image /page/3/Picture/0 description: The image shows the text "K001633 PAGE 4 OF 4". The text appears to be handwritten in black ink on a white background. The text is arranged in two lines, with the first line containing the alphanumeric code "K001633" and the second line indicating the page number as "PAGE 4 OF 4".
obtained in the continued access phase of the multi-center clinical trial and compared to that of the Tesio-Cath.
8. Do Performance Data Demonstrate Equivalence?
Yes. The performance of the LifeSite System was found to meet all clinically relevant acceptance criteria and was therefore acceptable. Where comparative testing was conducted, the LifeSite System performance was equivalent to or better than that of the relevant predicate performance was acceptable based on clinically relevant criteria.
SUBSTANTIALLY EQUIVALENT DETERMINATION:
The Vasca LifeSite Hemodialysis Access System is substantially equivalent to predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2000
Mr. Douglas E. Ferguson Regulatory Affairs Manager Vasca, Inc. 3 Highwood Drive Tewksbury, Massachusetts 01876
Re: K001633
Vasca LifeSite® Hemodialysis Access System Regulatory Class: III 21 CFR §876.5540/Procode: 78 MSD Dated: May 25, 2000 Received: May 26, 2000
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). 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. 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, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains a 70% isopropy alcohol solution which is subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
5
Page 2 - Mr. Douglas Ferguson
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
D. INDICATIONS FOR USE
Vasca LifeSite® Hemodialysis Access System Device Name:
Indications for Use:
The LifeSite® Hemodialysis Access System provides fully-implantable blood access for
es of the security the back is a bile working for ereation and/or maturation of The LifeSite® Hemodialysis Access Jysion pro reason and/or maturation of
patients who require hemodialysis while waiting for creation and/or math the patients who require nemodialysis while wasn't is used in conjunction with the permanent access. A 70% isopropyr acconor solarion solones.
LifeSite System for the localized cleansing of the injection site, valve pocket, and LifeSite valve.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision: Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 00 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________