(24 days)
Not Found
No
The summary describes a PICC kit and its intended use, focusing on physical components and procedural aids. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as providing "peripheral access to the central venous system for intravenous therapy" and for "administration of fluids, medications and nutrients," "sampling of blood," and "central venous pressure monitoring," which are diagnostic and support functions rather than therapeutic.
No
Explanation: The device is a Peripherally Inserted Central Catheter (PICC) used for intravenous therapy, administration of fluids, medications, nutrients, blood sampling, central venous pressure monitoring, and power injection of contrast media. These are therapeutic and monitoring functions, not diagnostic functions that identify or characterize a disease or condition.
No
The device description explicitly states it is a "packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices". This indicates the device is a physical kit containing hardware components (the PICC catheter and other procedural aides/barrier devices), not solely 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 a device used for accessing the central venous system for administering fluids, medications, nutrients, sampling blood, and monitoring central venous pressure. These are all direct patient care activities performed in vivo (within the body).
- Device Description: The device is described as a PICC (Peripherally Inserted Central Catheter) and a kit containing procedural aides and barrier precautions for its placement. This aligns with a medical device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The sampling of blood mentioned is for collection, not for analysis by this specific device.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. This device is a catheter used for accessing the circulatory system for therapeutic and monitoring purposes.
N/A
Intended Use / Indications for Use
PICC Maximal Sterile Barrier Kit with NMI HPICC III - NON-VALVED VERSION: The NMI HPICC III 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 central venous pressure monitoring 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 NMI HPICC III is 6 mL/sec.
PICC Maximal Sterile Barrier Kit with NMI PICC III - NON-VALVED VERSION: The NMI PICC III 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, for central venous pressure monitoring and for power injection of contrast media. Maximum Power Injection Flow Rate: 4F Single Lumen/55 cm 3.5 mL/sec, 5F Single Lumen/55 cm 5 mL/sec, 5F Dual Lumen/55 cm 4 mL/sec, 6F Dual Lumen/55 cm 5 mL/sec.
PICC Maximal Sterile Barrier Kit with NMI PICC III - VALVED VERSION: The NMI PICC III 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. Maximum Power Injection Flow Rate: 3F Single Lumen/55 cm 1 mL/sec, 4F Single Lumen/55 cm 3.5 mL/sec, 5F Single Lumen/55 cm 5 mL/sec, 5F Dual Lumen/55 cm 4 mL/sec, 6F Dual Lumen/55 cm 5 mL/sec, 6F Triple Lumen/55 – 6 mL/sec.
PICC Maximal Sterile Barrier 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 Maximal Sterile Barrier 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).
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
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)
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 Maximal Barrier Nursing Kit was conducted based upon a risk analysis and included testing conducted in accordance with the following national/international standards and FDA guidance documents:
- A AMI/ANSI/ISO 10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals (2008)
- AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
- A AMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)
- Deciding When to Submit a 510(k) for a Change to an Existing Device, 10 January 1997
- Convenience Kits, Interim Regulatory Guidance: 20 May 1997
- Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002
- Bundling Multiple Devices or Multiple Indications in a Single Submission: 22 June 2007
Safety and Performance Testing: The successful results of the following key tests demonstrate that the proposed PICC Maximal Barrier Nursing Kit has met the pre-determined acceptance criteria applicable to the safe use of the devices.
- Packaging Standards Testing
- EO Sterilization Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122882, K121089, K111906, K093366, K091261, K070002
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Premarket Notification PICC Maximal Barrier Nursing Kit
MAY 9 2013
Navilyst
Medical
26 Forest Street Marlborough. MA 01752 Tel 508,658.7990
510(k) Summary for the PICC Maximal Barrier Nursing Kit
or
Date prepared: 11 April 2013
A. Sponsor Navilyst Medical, Inc. 26 Forest Street
Marlborough, MA 01752
B. Contact
Marion W. Gordon Sr. Project Manager Global Regulatory Affairs Phone: 508-658-7942
C. Device Name
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
D. Predicate Device
Common/Usual name: Classification Name:
Premarket Notification
Lorraine M. Hanley Vice President Global Regulatory Affairs Phone: 508-494-1129
PICC Maximal Barrier Nursing Kits Peripherally Inserted Central Catheter (PICC) Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class II General Hospital Device Panel
Peripherally Inserted Central Catheter (PICC) Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class II K122882, K121089, K111906, K093366, K091261, K070002
E. Device Description
The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).
1
F. Intended Uses
· PICC Maximal Sterile Barrier Kit with NMI HPICC III
NON-VALVED VERSION
The NMI HPICC III 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 central venous pressure monitoring 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 NMI HPICC III is 6 mL/sec.
· PICC Maximal Sterile Barrier Kit with NMI PICC III
NON-VALVED VERSION
The NMI PICC III 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, for central venous pressure monitoring and for power injection of contrast media.
Maximum Power Injection Flow Rate:
- 4F Single Lumen/55 cm 3.5 mL/sec .
- 5F Single Lumen/55 cm 5 mL/sec ◆
- 5F Dual Lumen/55 cm 4 mL/sec ●
- 6F Dual Lumen/55 cm 5 mL/sec .
VALVED VERSION
The NMI PICC III 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.
Maximum Power Injection Flow Rate:
- . 3F Single Lumen/55 cm 1 mL/sec
- 4F Single Lumen/55 cm 3.5 mL/sec ●
- 5F Single Lumen/55 cm 5 mL/sec .
- ◆ 5F Dual Lumen/55 cm 4 mL/sec
- 6F Dual Lumen/55 cm 5 mL/sec .
- . 6F Triple Lumen/55 – 6 mL/sec
- · PICC Maximal Sterile Barrier 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.
2
· PICC Maximal Sterile Barrier 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.
G. Summary of Similarities and Differences in Technological Characteristics and Performance
Similarities
The proposed PICC Maximal Barrier Nursing Kit contains one of the identified predicate PICCs packaged with a variety of procedural aide componentry typically used during PICC placement. The proposed PICC indications for use, technological characteristics, materials and operating principles are identical.
Differences
The proposed packaging configuration differs from the predicate PICC kit packaging in order to contain a selection of procedural aides used in PICC placement including those identified as maximal barrier precaution devices. 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 Maximal Barrier Nursing Kit was conducted based upon a risk analysis and included testing conducted in accordance with the following national/international standards and FDA guidance documents:
- . A AMI/ANSI/ISO 10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals (2008)
- AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: ◆ Requirements for materials, sterile barrier systems, and packaging systems (2006)
- . A AMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)
- Deciding When to Submit a 510(k) for a Change to an Existing Device, 10 January 1997 .
- Convenience Kits, Interim Regulatory Guidance: 20 May 1997 �
- Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002 .
- Bundling Multiple Devices or Multiple Indications in a Single Submission: 22 June 2007 ●
Safety and Performance Testing l.
Tests:
The successful results of the following key tests demonstrate that the proposed PICC Maximal Barrier Nursing Kit has met the pre-determined acceptance criteria applicable to the safe use of the devices.
-
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 Maximal Barrier Nursing 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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 9, 2013
Ms. Marion W. Gordon Senior Project Manager Navilyst Medical, Incorporated 26 Forest Street MARLBOROUGH, MA 01752
Re: K131038
Trade/Device Name: PICC Maximal Barrier Nursing Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 11, 2013 Received: April 17, 2013
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
Page 2 - Ms. Gordon
Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 vours.
Image /page/4/Picture/8 description: The image contains a handwritten note with the word "for" at the top left. The note also includes the words "with" and what appears to be a name or word that is difficult to decipher due to the handwriting style. There are also some decorative swirls and lines around the text, adding a personal touch to the note.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital,
. Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if Known):
Device Name:
PICC Maximal Barrier Nursing Kit
with NMI PICC III
Indications for Use:
NON-VALVED VERSION
The NMI PICC III 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, for central venous pressure monitoring and for power injection of contrast media.
Maximum Power Injection Flow Rate:
- 4F Single Lumen/55 cm 3.5 mL/sec .
- 5F Single Lumen/55 cm 5 mL/sec .
- 5F Dual Lumen/55 cm 4 mL/sec .
- 6F Dual Lumen/55 cm 5 mL/sec .
VALVED VERSION
The NMI PICC III with PASV Vale Technology 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.
Maximum Power Injection Flow Rate:
- 3F Single Lumen/55 cm 1 mL/sec ●
- 4F Single Lumen/55 cm 3.5 mL/sec .
- 5F Single Lumen/55 cm 5 mL/sec .
- 5F Dual Lumen/55 cm 4 mL/sec .
- 6F Dual Lumen/55 cm 5 mL/sec .
- 6F Triple Lumen/55 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)
Kathleen E. Fitzgerald 200 Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
6
Indications for Use
510(k) Number (if Known):
Device Name:
PICC Maximal Barrier Nursing Kit
NMI HPICC III with i
Indications for Use:
NON-VALVED VERSION
The NMI HPICC III 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 central venous pressure monitoring 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 NMI HPICC III 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)
Kathle 300.100.1-1=0010093027. Fitzger
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: K131038
4-2
D
7
510(k) Premarket Notification PICC Maximal Barrier Nursing Kit
Indications for Use
510(k) Number (if Known):
Device Name:
PICC Maximal Barrier Nursing Kit
Xcela® Hybrid PICC with PASV® Valve Technology with
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)
"
区 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)
Image /page/7/Picture/14 description: The image shows the letters FDA in a stylized, outlined font. The letters are interconnected and have a three-dimensional appearance due to the multiple outlines. The overall design is simple and recognizable, likely representing the Food and Drug Administration.
Richard C. Chapman 2013.05.07 12:39:02 -04'00'
(Division Sign-Off) (Division Sign-Cor)
Division of Anesthesiology. General Hospital Division of Anesian Devices
510(k) Number: K131038
8
510(k) Premarket Notification PICC Maximal Barrier Nursing Kit
Indications for Use
| 510(k) Number (if Known): | |
|---|---|
| Device Name: | PICC Maximal Barrier Nursing Kit |
| with NMI PICC II | |
| Or | |
| PICC Maximal Barrier Nursing Kit | |
| with NMI PICC | |
| Or | |
| PICC Maximal Barrier Nursing Kit | |
| 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) ಸ 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)
Kathleen E
Fitzgerald
Digitally signed by Kathleen E. Fitzgerald
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1-0010093027,
cn=Kathleen E. Fitzgerald
Date: 2013.05.09 15:27:31 -04'00'
(Division Sign-Off) (Division of Anesthesiology, General Hospital Intection Control, Dental Devices
510(k) Number: