(88 days)
The Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
The r4 Vascular. Inc. Zeus™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling, power injection of contrast media studies and central venous pressure monitoring. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each Zeus™ CT PICC has a kink resistant reverse tapered catheter design. The Zeus™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The Zeus™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen.
The Zeus™ CT PICC is similar to HDC's V-Cath (Polyurethane) Power PICC (Power-V), with the addition of a Biomimetic Coating that is similar in performance to the Tyco Palindrome Emerald.
The provided text is a 510(k) summary for a medical device (Zeus™ CT PICC), which focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a comprehensive study report with the requested elements. Therefore, many of the requested details are not explicitly present in the provided document.
However, based on the information that is available, here's an attempt to answer your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that the device "met all established acceptance criteria for performance testing and design verification testing." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The document refers to various standards (e.g., ISO 10555-1:1997, ISO 594, AAMI/ANSI/ISO 11135:1994, ISO 10993) that would contain these criteria, but doesn't list them or the specific results.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Performance testing was generated in accordance with the above referenced guidance document and standards." However, the sample size used for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in a full study report, not a 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the given text. The evaluations mentioned are performance testing based on established standards, likely involving engineering or lab-based assessments rather than human expert opinion for ground truth.
4. Adjudication Method
This information is not provided. Given the nature of the testing described (performance testing against standards), formal adjudication methods like 2+1 or 3+1 by human experts would not typically apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence for a medical device (PICC catheter), not on evaluating the improvement of human readers with AI assistance. Therefore, no effect size of human improvement with AI is provided.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study is mentioned. This device is a physical medical catheter, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance testing of this device would be the physical and chemical specifications outlined in the referenced international and FDA standards (e.g., ISO 10555-1 for intravascular catheters, ISO 594 for Luer taper, ISO 11135 for sterilization, ISO 10993 for biocompatibility). The device's performance was measured against these established standards to ensure safety and effectiveness.
8. Sample Size for the Training Set
This information is not applicable and not provided. The Zeus™ CT PICC is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, this is not an AI device.
In summary, the provided 510(k) summary focuses on regulatory compliance and demonstrating substantial equivalence through adherence to recognized standards and guidance documents for a medical device. It does not contain the detailed study information typically requested when evaluating an AI/ML algorithm or a diagnostic tool that relies on human interpretation.
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II
SECTION 5.0
510(k) Summary
SUBMITTER: R4 Vascular, Inc. 7550 Meridian Circle Suite 150
Maple Grove, MN 55369
ESTABLISHMENT REGISTRATION NUMBER: 3006242715
CONTACT:
Laurie Lewandowski Director, Quality and Regulatory Affairs Telephone: 612-770-4038 cell Telephone: 763-494-8400 Fax: 763-494-8484 Email: lalew@r4vascular.com
DATE PREPARED:
December 16, 2008
NAME OF MEDICAL DEVICE:
Zeus™ CT PICC Proprietary Name: Percutaneous, implanted, long-term intravascular catheter Regulation Name: Peripherally Inserted Central Catheter (PICC), single and double Common/Usual Name: lumen
DEVICE CLASSIFICATION:
| Classification Panel: | General Hospital |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Regulation Number: | 21 CFR 880.5970 |
PREDICATE DEVICES:
Proprietary Name: V-Cath (Polyurethane) Power PICC (Power-V) ・ Peripherally Inserted Central Catheter (PICC), single and double Common/Usual Name: lumen
| Proprietary Name: | Tyco Palindrome Emerald |
|---|---|
| Regulation Name: | Chronic Hemodialysis Catheter |
| Common/Usual Name: | Catheter, Hemodialysis, Apheresis, Intravascular |
| Device Description: |
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The r4 Vascular. Inc. Zeus™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling, power injection of contrast media studies and central venous pressure monitoring. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each Zeus™ CT PICC has a kink resistant reverse tapered catheter design. The Zeus™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The Zeus™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen.
The Zeus™ CT PICC is similar to HDC's V-Cath (Polyurethane) Power PICC (Power-V), with the addition of a Biomimetic Coating that is similar in performance to the Tyco Palindrome Emerald.
Intended Use / Indication for Use:
The Zeus "M CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
Technological Comparison to Predicate Devices:
The technological characteristics of the Zeus™ CT PICC are substantially equivalent to the predicates, HDC's V-Cath (Polyurethane) Power PICC (Power-V) and Tyco Palindrome Emerald in terms of intended use, application, user population, basic design, performance and labeling.
New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.
Does the new device have the same indication statements? Yes.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.
Docs the new device have the same technological characteristics, e.g. design, material, etc. ? Not in all regards. The principles of operations and basic design are the same as the predicate devices. The main change in design is the addition of the biomimetic coating to the catheter.
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There is precedence in the market for coated catheters. Tyco Palindrome Emerald and their predicates.
Could the new characteristics affect safety or effectiveness? Yes. The changes may affect safety and effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions? No. Therc are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
Yes. Testing was based on FDA guidance documents and recognized standards to evaluate the devices' performance.
- The FDA's Guidance on Premarket Notification [5] 0/k)] Submission for Short-Term and o Long-Term Intravascular Catheters, dated 3/16/95 was used to determine the appropriate methods for evaluating the device's performance.
- ISO 10555-1:1997 Sterile, Single-use Intravascular Catheters, General requirements; o
- ISO 594 Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other o medical equipment-Part1: General requirements
- AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of 0 Ethylene Oxide Sterilization
- ISO 10993 Biological Evaluation of Medical Devices Part-1 : Evaluation and Testing o
Sterilization requirements of ISO 11135:2007, Sterilization of Health Care Products - Reguirements for Validation and Routine Control -- Ethylene Oxide Sterilization.
Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, bloodcontacting, long-term devices will be met.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance data available to assess effects of new characteristics? Yes. Performance testing was generated in accordance with the above referenced guidance document and standards.
Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrate that the Zeus™ CT PICC with biomimetic coating met the performance criteria of safety and effectiveness test performed and based on the FDA's decision tree is substantially equivalent to the noted predicate devices.
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K083763 4 of 4 14
CONCLUSION
The Zeus™ CT PICC met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the Zeus™ CT PICC is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices: HDC V-Cath (Polyurethane) Power PICC (Power-V) and Tyco Palindrome Emerald.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus. The logo is presented in black and white.
MAR 2 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laurie Lewandowski Director, Quality and Regulatory Affairs R4 Vascular, Incorporated 7550 Meridian Circle North Suite 150 Maple Grove, Minnesota 55369
Re: K083763 Trade/Device Name: Zeus CT PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class; II Product Code: LJS Dated: December 16, 2008 Received: December 18, 2008
Dear Ms. Lewandowski:
This letter corrects our substantially equivalent letter of March 16, 2009.
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 (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.
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Page 2 - Ms. Lewandowski
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Ingite L. Michael Omid
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology. General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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r4 Vascular, Inc. 510(k) Premarket Notification Submission: Zeus™ CT PICC
Page 10
Section 4.0
Indications for Use
510(k) Number (if known): K083763
Device Name: Zeus CT PICC
Indications For Use:
The Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommednded infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083763
Page 1 of 1
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”