(13 days)
For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
The proposed PICC has similar technological characteristics as the predicate devices. lt is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
It appears that the provided FDA 510(k) summary (K091261 for Navilyst Medical's PICC) does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and a specific study's results.
The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance testing. It does not present a specific clinical study with detailed performance metrics against predefined acceptance criteria in the format you've requested.
However, I can extract what is available and highlight where information is missing based on your prompt.
Analysis of K091261 for Acceptance Criteria and Study Information
Summary of Findings:
The 510(k) submission primarily relies on in-vitro testing and biocompatibility assessments to demonstrate substantial equivalence, rather than a clinical study with detailed performance outcomes against specific, quantitative acceptance criteria. Therefore, most of the requested fields cannot be filled directly from the provided text.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected/Implied) | Reported Device Performance (from K091261) |
|---|---|---|
| Mechanical Performance | Adherence to ISO 10555-3 standards for intravascular catheters. | "in-vitro testing in accordance with ISO 10555-3" (Pass/Fail implied, but no specific values or thresholds reported). |
| Power Injection | Maintenance of integrity and specified flow rates during high-pressure injection. | "high pressure injection flow rates" (Pass/Fail implied, indicating the device can withstand and facilitate power injection as indicated, but no specific flow rates or pressure limits are reported here). |
| Valve Integrity | Functionality and sealing capabilities of the pressure-activated safety valve. | "valve integrity testing" (Pass/Fail implied, but no specific leak rates or pressure limits reported here). |
| Biocompatibility | Compliance with ISO 10993-1 for biological evaluation of medical devices. | "biocompatibility evaluation in accordance with ISO 10993-1" (Pass/Fail implied, but no specific test results or cytotoxicity/sensitization levels reported). |
| Clinical Efficacy/Safety | Not explicitly defined in the document for a new device study. | Not applicable in this context; not a clinical trial. |
Missing Information/Why it Can't be Fully Addressed from provided text:
The provided text only lists the types of performance testing conducted (ISO 10555-3, high pressure injection, valve integrity, biocompatibility). It does not:
- Specify quantitative acceptance criteria for each test (e.g., "tensile strength must be >X N," "flow rate must be >Y mL/s at Z psi").
- Report specific performance values or statistical outcomes from these tests.
- Describe a clinical study with patient outcomes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions in-vitro testing but does not provide the number of units tested.
- Data Provenance: In-vitro laboratory testing. The country of origin for the lab testing is not specified but would typically be conducted at the manufacturer's R&D facilities or a contract lab. This is not clinical data (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This information is relevant for studies involving human interpretation (e.g., imaging, diagnostics). The tests described are in-vitro physical and material tests, not expert-adjudicated clinical data.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing involves objective measurements against established engineering standards, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. This device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers. The submission does not describe any clinical study, let alone an MRMC study.
- Effect Size of Human Readers (with/without AI): Not applicable.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
- For the in-vitro tests: The "ground truth" is defined by established engineering standards (e.g., ISO 10555-3) and internal design specifications for mechanical, flow, and biocompatibility properties. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- Not applicable. This concept typically applies to machine learning algorithms. The development of a physical medical device involves design, prototyping, and in-vitro testing, but not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
Conclusion:
The provided 510(k) summary for K091261 demonstrates substantial equivalence through a comparison of technological characteristics with predicate devices and compliance with relevant in-vitro and biocompatibility standards. It does not present a clinical study with detailed performance metrics against quantitative acceptance criteria in the manner you've outlined for AI or diagnostic devices.
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Image /page/0/Picture/1 description: The image shows the logo for Navilyst Medical. The logo consists of a stylized globe on the left, followed by the company name "Navilyst" in a sans-serif font. Below "Navilyst" is the word "Medical" in a smaller, italicized font. The overall design is simple and professional.
MAY 12 2009
26 Forest Street Marlborough, MA 01752 Tel 508.658.7990
510(k) Summary
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Nicholas Condakes Manager, Regulatory Affairs or 508-658-7931
Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945
C. Device Name
| Tradename: | To be determined |
|---|---|
| Common/usual name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Long term intravascular catheter21 CFR 880.5970, Class II |
D. Predicate Device(s)
Peripherally Inserted Central Catheter (PICC) Common/usual name: Classification Name: LJS- Long term intravascular catheter, 21 CFR 880.5970, Class II Premarket Notification(s): K070002, K021704
E. Device Description
The proposed PICC has similar technological characteristics as the predicate devices. lt is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.
F. Intended Use
The proposed device is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
G. Performance Data
Performance testing included in-virro testing in accordance with ISO 10555-3; high pressure injection flow rates; and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1.
H. Substantial Equivalence
Based on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicates.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
MAY 12 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Nicholas Condakes Regulatory Affairs Manager Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752
Re: K091261
Trade/Device Name: Undetermined Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 28, 2009 Received: April 29, 2009
Dear Mr. Condakes:
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 docs 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
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Page 2- Mr. Condakes
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Antony O, me for
Susan Runner, D.D.S., MA 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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Indications for Use
510(k) Number (if Known):
Device Name:
To be determined
Indications For Use: For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR Over-The-Counter Use_
(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)
Light Illusions for ABC LCDR Colburn 05/10/2009
(Division Sign-Off)
Division of Anesthesionogy, General Hospital Infection Control, Dential Devices
510(k) Number:
§ 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.”