(55 days)
No
The description focuses on the physical characteristics and intended use of a hemodialysis catheter, with no mention of AI or ML capabilities.
Yes
The device is indicated for long-term vascular access for hemodialysis and apheresis, which are therapeutic procedures.
No
Explanation: The device is a catheter for vascular access during hemodialysis and apheresis, not for diagnosing a medical condition. Its purpose is to facilitate treatment by providing access for blood outflow and return, not to detect or identify diseases.
No
The device description clearly describes a physical catheter made of polyurethane material, intended for insertion into veins. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The NovoFlo™ Catheter is a device that is inserted into the body (specifically, veins) to facilitate the process of hemodialysis and apheresis. It is a direct interface with the patient's circulatory system for the purpose of blood removal and return.
- Intended Use: The intended use clearly states it's for "attaining long term vascular access for hemodialysis and apheresis." This is a therapeutic and access function, not a diagnostic testing function performed on samples outside the body.
The device description and intended use clearly indicate it's an invasive medical device used for treatment and access, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
- The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining Long Term vascular access for hemodialysis and apheresis.
- It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required.
- Catheters greater than 40cm in length are intended for femoral vein insertion.
Product codes
MSD
Device Description
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is manufactured from soft radiopaque polyurethane material which provides increased patient comfort while providing excellent biocompatibility.
The Hemodialysis Catheter can be connected to an extracorporeal tubing system via a connecting tube equipped with a Luer-Lock connector.
The proximal lumen (red clamp) provides "arterial" blood outflow from the patient, the distal lumen (blue clamp) provides "venous" blood return to the patient. Important information such as priming volume and catheter length is printed on both sides of the clamp.
The catheter comes in a variety of sizes and lengths with straight or curved extensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein, femoral vein
Indicated Patient Age Range
adult patient
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)
Engineering studies were performed to FDA's "Guidance on Premarket Notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters", and "Coronary and Cerebrovascular Guidewire Guidance", ISO 10555 - International standard for "Sterile, Single-Use, Intravascular Catheters, ISO 10993 - International standard for "Biological Evaluation of Medical Devices", and additional test requirements for hemodialysis catheters.
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter was demonstrated to be substantially equivalent to the predicate device based on its design, test results, and indications for use.
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.
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K072499 page 1 of 2
510(k) Summary
ﻧﯽ ﮐﮯ ﻣ 2011/0
1. Contact Information
| Submitter: | NovoSci, Inc.
2828 N. Crescent Ridge Drive
The Woodlands, TX 77381 |
|-----------------|--------------------------------------------------------------------------|
| | 405.826.0713 Phone
888.795.1609 Fax |
| Contact Person: | David Makanani |
| Date Prepared: | October 15, 2007 |
| Trade: | NovoFlo™ Catheter I.T Dual Lumen Long Term Hemodialy |
2. [
| Trade: | NovoFloTM Catheter LT Dual Lumen Long Term Hemodialysis
Catheter |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Hemodialysis Long Term Catheter |
| Classification Name: | 78 MSD – Catheter, Hemodialysis, Implanted
21 CFR 876.5540 |
3. Predicate Device
Medcomp Hemo-Flow Catheter, K994105 Medcomp Hemo-Flow Catheter, K030502
4. Description of Device
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is manufactured from soft radiopaque polyurethane material which provides increased patient comfort while providing excellent biocompatibility.
The Hemodialysis Catheter can be connected to an extracorporeal tubing system via a connecting tube equipped with a Luer-Lock connector.
The proximal lumen (red clamp) provides "arterial" blood outflow from the patient, the distal lumen (blue clamp) provides "venous" blood return to the patient. Important information such as priming volume and catheter length is printed on both sides of the clamp.
The catheter comes in a variety of sizes and lengths with straight or curved extensions.
5. Indications for Use
- . The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining Long Term vascular access for hemodialysis and apheresis.
- It may be inserted percutaneously and is primarily placed in the internal jugular vein of an . adult patient. Alternate insertion sites include the subclavian vein as required.
- Catheters greater than 40cm in length are intended for femoral vein insertion. .
1
K072499 pase 2 of 2
6. Comparison to Predicate Device
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is substantially equivalent to the Medcomp Hemo-Flow Long Term Catheter.
A close examination of specifications reveals that there are no major differences in design, materials, performance, biocompatibility, safety and product effectiveness.
7. Non-clinical Performance Tests:
Engineering studies were performed to FDA's "Guidance on Premarket Notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters", and "Coronary and Cerebrovascular Guidewire Guidance", ISO 10555 - International standard for "Sterile, Single-Use, Intravascular Catheters, ISO 10993 - International standard for "Biological Evaluation of Medical Devices", and additional test requirements for hemodialysis catheters.
8. Conclusion
The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter was demonstrated to be substantially equivalent to the predicate device based on its design, test results, and indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Makanani Vice-President NovoSci, Inc. 2828 N. Crescent Ridge Drive WOODLANDS TX 77281
OCT 3 0 2007
Re: K072499
Trade/Device Name: NovoFlo" Catheter LT Dual Lumen 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 31, 2007 Received: September 5, 2007
Dear Mr. Makanani:
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.
3
Page 2 - Mr. David Makanani
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 (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 (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,
Herbert Semler
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K072499
NovoFlo™ Catheter LT Dual Lumen Long Term Device Name: __
Hemodialysis Catheter Indications for Use:
- The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis . Catheters are indicated for use in attaining long term vascular access for hemodialysis and apheresis.
- It may be inserted percutaneously and is primarily placed in the internal . jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required.
- Catheters greater than 40cm in length are intended for femoral vein . insertion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K072499 |
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