(28 days)
Not Found
No
The summary describes a physical medical device (PICC Convenience Kit) and its intended use and performance testing, with no mention of software, algorithms, AI, or ML.
Yes.
The device is used for intravenous therapy, including the administration of fluids, medications, nutrients, and for blood sampling, all of which are considered therapeutic interventions.
No
Explanation: The device is a PICC (Peripherally Inserted Central Catheter) Convenience Kit, which is used for delivering fluids, medications, and nutrients, and for sampling blood. It facilitates intravenous therapy and central venous access, but it does not diagnose medical conditions.
No
The device description explicitly states it includes "packaging configurations that will accommodate a specified NMI PICC and other legally marketed procedural aides typically used during clinical placement," indicating it is a kit containing physical medical devices, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for accessing the central venous system for administering fluids, medications, nutrients, and for blood sampling and power injection of contrast media. These are all procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description mentions a PICC and procedural aides used during clinical placement, which aligns with a device used for direct patient access.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used on samples taken from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device is used for direct access to the patient's circulatory system for therapeutic and sampling purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
· PICC Convenience Kit with Xcela® Hybrid with PASV® Valve Technology: 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.
· PICC Convenience Kit with NMI PICC II; or with NMI PICC; or with BSC PICC: 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.
- · PICC Convenience Kit with Vaxcel® PICC with PASV® Valve Technology: for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.
Product codes
LJS
Device Description
The PICC Convenience Kit includes packaging configurations that will accommodate a specified NMI PICC and other legally marketed procedural aides typically used during clinical placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
adults, children, and infants
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 performance evaluation of the PICC Convenience Kit was conducted based upon a risk analysis and included testing conducted in accordance with the following national/international standards and FDA guidance documents:
- AAMI/ANSI/ISO Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization . residuals (2008)
- A AMI/ANSI/ISO 11601-1 Packaging for terminally sterilized medical devices-Part 1: . Requirements for materials, sterile barrier systems, and packaging systems (2006)
- A AMI/ANSI/ISO 11601-2 Packaging for terminally sterilized medical devices Part 2: Validation t requirements for forming, sealing and assembly processes (2006)
- FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997 .
- FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002 .
Safety and Performance Testing I.
The successful results of the following key tests demonstrate that the proposed NMI PICC Convenience Kits have met the pre-determined acceptance criteria applicable to the safe use of the devices.
Tests:
- Packaging Standards Testing
- EO Sterilization Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111906, K101326, K093366, K091261, K070002, K021704
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
3 2012 AUG
26 Forest Street Marlborough, MA D1752 Tel 508.658.7990
ww.navilyslmedical.com
Date prepared: 5 July 2012
510(k) Summary for the PICC Convenience Kit
Sponsor
Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752
B. Contact
A.
Marion W. Gordon Sr. Manager Global Regulatory Affairs Phone: 508-658-7942
C. Device Name
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
D. Predicate Device
Trade Name: Common/Usual name: Classification Name:
Premarket Notification
or
Lorraine M. Hanley Vice President Global Regulatory Affairs Phone: 508-494-1129
PICC Convenience Kit
PICC Convenience Kit
Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class Il General Hospital Device Panel
PICC Convenience Kit
Peripherally Inserted Central Catheter (PICC) Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class II K111906, K101326, K093366, K091261, K070002, K021704
E. Device Description
The PICC Convenience Kit includes packaging configurations that will accommodate a specified NMI PICC and other legally marketed procedural aides typically used during clinical placement.
1
F. Intended Uses
· PICC Convenience Kit with Xcela® Hybrid with PASV® Valve Technology:
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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.
· PICC Convenience Kit with NMI PICC II; or with NMI PICC; or with BSC PICC:
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.
- · PICC Convenience Kit with Vaxcel® PICC with PASV® Valve Technology:
for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.
G. Summary of Similarities and Differences in Technological Characteristics and Performance
Similarities
The proposed PICC Convenience Kit contains one of the identified predicate PICCs packaged with a variety of procedural aide componentry typically used during PICC placement.
Differences
The proposed packaging configurations differ from the predicate PICC packaging in order to contain a broader selection of procedural aides used in PICC placement. All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry.
H. Performance
No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. The performance evaluation of the PICC Convenience Kit was conducted based upon a risk analysis and included testing conducted in accordance with the following national/international standards and FDA guidance documents:
- AAMI/ANSI/ISO Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization . residuals (2008)
- A AMI/ANSI/ISO 11601-1 Packaging for terminally sterilized medical devices-Part 1: . Requirements for materials, sterile barrier systems, and packaging systems (2006)
- A AMI/ANSI/ISO 11601-2 Packaging for terminally sterilized medical devices Part 2: Validation t requirements for forming, sealing and assembly processes (2006)
- FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997 .
- FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002 .
2
Safety and Performance Testing I.
The successful results of the following key tests demonstrate that the proposed NMI PICC Convenience Kits have met the pre-determined acceptance criteria applicable to the safe use of the devices.
Tests:
-
Packaging Standards Testing
-
EO Sterilization Testing
J. Conclusion
Results of testing according to recognized standards and in consideration to the responses posed in FDA's Guidance on the CDRH Premarket Notification Review Program, 510(k) Decision Making Tree, the proposed PICC Convenience Kit is determined to be substantially equivalent to the predicate NMI PICCs.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3 2012 AUG
Ms. Marion W. Gordon Senior Manager, Global Regulatory Affairs Navilyst Medical Incorporated 26 Forest Street Marlborough, Massachusetts 01752
Re: K121990
Trade/Device Name: PICC Convenience Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 5, 2012 Received: July 6, 2012
Dear Ms. Gordon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
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); 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 (Sections 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
F
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if Known):
Device Name:
PICC Convenience Kit
with
Xcela® Hybrid PICC with PASV® Valve Technology
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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.
Prescription Use (21 CFR 801 Subpart D) × And/Or
AND/OR Over-The-Counter Use: (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)
Rld C. Olyn 8/2/12
(Division Sign-Off)
Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: 990
4-2
6
Indications for Use
510(k) Number (if Known):
Device Name:
PICC Convenience Kit with ́ NMI PICC II Or with NMI PICC Or with BSC PICC
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 (21 CFR 801 Subpart D) And/Or
ಹ
AND/OR Over-The-Counter Use: (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)
Rld C. Chyn 8/2/12
(Division Sign-Off)
Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K121990
7
Indications for Use
510(k) Number (if Known):
Device Name:
PICC Convenience Kit
Vaxcel® PICC with PASV® Valve Technology with
Indications for Use:
for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.
Prescription Use (21 CFR 801 Subpart D) ಸಿ And/Or AND/OR Over-The-Counter Use: (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)
Rell C. 8/2/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Denta. Devices
510(k) Number: K121998