(180 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a drainage catheter, with no mention of AI or ML.
Yes
The device is described as "ReLeaf catheters" and their intended use includes the application of anesthetic to relieve postoperative pain, which is a therapeutic function.
No
The device is described as a drainage tube and an anesthetic infusion line for postoperative pain relief, not for diagnosing conditions.
No
The device description clearly outlines a physical catheter with multiple lumens, a distal tip, and an insertion trocar. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the ReLeaf catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for draining fluids and exudates during or after surgery and for applying anesthetic to relieve postoperative pain. This is a direct interaction with the patient's body for therapeutic and drainage purposes.
- Device Description: The description details a catheter designed for insertion into the body to manage fluids and deliver substances.
- 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.
IVD devices are typically used to test samples like blood, urine, or tissue to detect diseases, conditions, or infections. The ReLeaf catheter's function is entirely focused on managing the patient's internal environment and delivering medication directly.
N/A
Intended Use / Indications for Use
ReLeaf catheters are intended for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.
Product codes (comma separated list FDA assigned to the subject device)
BSO, GCY
Device Description
The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench-top and animal testing was conducted to demonstrate that the differences in technological characteristics between the ReLeaf catheter and the predicate do not introduce any new issues of safety or effectiveness. Performance testing included insertion force, removal force, leak testing, patency, lumen compression, polymer leachables. fatigue strength, tensile strength, biocompatibility, tissue adherence and simulated use testing.
The performance testing results support a substantial equivalence determination by demonstrating that the ReLeaf catheter is safe and effective for its intended use.
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.
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
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
0
Traditional 510(k) Notification
ReLeaf™ Catheter
SECTION 5
FEB 2 7 2013
510(k) SUMMARY (21 CFR 870.92) ReLeaf™ Catheter
510(k) Owner:
Vital 5 LLC 570 Research Park Way, Suite 102 North Logan, UT 84341 Tel: 435-752-0307 Fax: 435-213-4878
Contact Person:
T. Wade Fallin Tel: 435-752-0307 e-mail: wade@venturemd.com
Date Prepared:
Trade Name:
Common Name:
Classification:
Product Code:
Predicate Device:
Device Description:
Intended Use:
ReLeafTM Catheter
August 29, 2012
Anesthesia Conduction Catheter and Apparatus Suction
Class II (21 CFR 868.5120) and Class I (21 CFR 878.4680)
BSO and GCY
Axiom Multipurpose Wound Drain (K993592)
The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.
ReLeaf catheters are intended for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.
The ReLeaf catheter indication statement is narrower than and fully encompassed by the predicate device's indications. Therefore
1
Traditional 510(k) Notification
neither the therapeutic effect nor the safety and effectiveness are impacted.
Vital 5 ReLeaf catheter has similar technological The characteristics to the Axiom Multipurpose Wound Drain. Both devices have multiple lumens for infusion of anesthetics and drainage of fluids within the surgical wound and are manufactured from radiopaque materials allowing for assessment of catheter placement after wound closure.
The materials used to manufacture the two devices and their coatings are different however this does not impact safety or effectiveness as the full battery of ISO 10993 testing has been passed by the ReLeaf catheter. The distal tip of the catheters contain a design difference with the ReLeaf catheter flaring into a broad flat sheet and the predicate remaining cylindrical in shape however this does not impact safety or effectiveness as the performance of the ReLeaf catheter has been confirmed for its intended use in bench testing and simulated use animal testing.
Bench-top and animal testing was conducted to demonstrate that the differences in technological characteristics between the ReLeaf catheter and the predicate do not introduce any new issues of safety or effectiveness. Performance testing included insertion force, removal force, leak testing, patency, lumen compression, polymer leachables. fatigue strength, tensile strength, biocompatibility, tissue adherence and simulated use testing.
The performance testing results support a substantial equivalence determination by demonstrating that the ReLeaf catheter is safe and effective for its intended use.
The ReLeaf catheter is substantially equivalent to the Axiom Multipurpose Wound Drain (K993592). regarding its intended use, indications for use and technological characteristics. No new issues of safety or effectiveness are introduced as a result of the differences in technological characteristics or indication statements.
Vital 5 LLC has determined that the ReLeaf catheter is substantially equivalent to the predicate device and safe and effective for its intended use.
Non-Clinical Performance Data:
Technological
Characteristics:
Conclusions:
Vital 5 LLC
Page 8 of 42
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of snakes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2013
Vital 5 % Mr. T. Wade Fallin President and Chief Executive Officer 570 Research Park Way, Suite 102 North Logan, Utah 84341
Re: K122661
Trade/Device Name: Vital 5 ReLeaf Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia conduction catheter Regulatory Class: Class II Product Code: BSO, GCY Dated: February 20, 2013 Received: February 21, 2013
Dear Mr. Fallin:
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.
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 mustcomply 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
3
Page 2 - Mr. T. Wade Fallin
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, FOR Peter Dag Muimm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) Notification
ReLeaf™ Catheter
SECTION 4
Indications for Use Statement
510(K) Number (if know): _____________________________________________________________________________________________________________________________________________________ K122661
Device Name: Vital 5 ReLeaf Catheter
Indications for Use:
ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen
(Division Sign-off) Division of Surgical Devices 510(k) Number K122661
Vital 5 LLC
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