(49 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven analysis.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for "therapeutic applications."
Yes
The 'Intended Use / Indications for Use' section states that the device is "indicated for use in interventional, diagnostic, surgical, and therapeutic applications".
No
The device description explicitly states the adapters are comprised of "individually molded polycarbonate parts" and are bonded together, indicating a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to "interconnect tubing, catheters, or other devices" in various medical applications (interventional, diagnostic, surgical, therapeutic). This is a mechanical function for connecting medical equipment, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description details the physical components and how they are assembled. This aligns with a device used for fluid or gas transfer and connection, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or other components typically associated with IVD tests
The device is a medical accessory used in procedures, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
Merit's Rotating Adapters are indicated for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
Product codes (comma separated list FDA assigned to the subject device)
DTL
Device Description
Merit's Rotating Adapters are marketed in two configurations: Male-Male Adapter (MMA) and Male-Female Adapter (MFA). The adapters are comprised of a stand-alone rotator assembly bonded to a polycarbonate male or female luer lock, using a UV cured adhesive. The stand-alone rotator assembly is comprised of individually molded polycarbonate parts (housing connector, retaining collar, hub) and an
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)
Performance testing of the subject Rotating Adapters was conducted based on the risk analysis and based on the requirements of the following international standards: ISO 8536-4:2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed ISO 8536-10:2004, Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - routine control of a sterilization process for medical devices ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part. 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials United States Pharmacopeia 36, National Formulary 31, 2013 Pyrogen Test. Test conducted: Merit Rotational Torque Test, Merit Hydrostatic Pressure Test, Merit Vacuum Leak Test, ISO 8536-4 Chemical Requirements, ISO 8536-10 Particulate, ISO 8536-10 Leakage, Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Systemic Injection, Pyrogenicity, Hemocompatibility, Chemical Characterization. The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
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
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Merit Rotating Adapter
Premarket Notification 510(k)
"
""""
Merit Medical Systems, Inc.
5.0 510(k) Summary
APR | 6 2014
| General
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (801) 316-3690 | |
| Fax Number: | (801) 826-4112 | |
| Contact Person: | Mr. Cory Marsh | |
| Date of Preparation: | February 24, 2014 | |
| Registration Number: | 1721504 | |
| Subject Device | Trade Name: | Rotating Adapter |
| Common/Usual Name: | Adapter/Connector | |
| Classification Name: | Cardiopulmonary bypass adapter, stopcock, | |
| manifold or fitting | ||
| Predicate | ||
| Device | Trade Name: | Rotator; male-male, male-female |
| Classification Name: | Cardiopulmonary bypass adapter, stopcock, | |
| manifold or fitting | ||
| Premarket Notification: | K932251 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II | |
| 21 CFR § 870.4290 | ||
| FDA Product Code: DTL | ||
| Review Panel: Cardiovascular | ||
| Intended Use | Merit's Rotating Adapters are indicated for use in interventional, | |
| diagnostic, surgical, and therapeutic applications to interconnect tubing, | ||
| catheters, or other devices. | ||
| Device | ||
| Description | Merit's Rotating Adapters are marketed in two configurations: Male- | |
| Male Adapter (MMA) and Male-Female Adapter (MFA). The adapters | ||
| are comprised of a stand-alone rotator assembly bonded to a | ||
| polycarbonate male or female luer lock, using a UV cured adhesive. | ||
| The stand-alone rotator assembly is comprised of individually molded | ||
| polycarbonate parts (housing connector, retaining collar, hub) and an |
1
Merit Rotating Adapter
Premarket Notification 510(k)
Merit Medical Systems, Inc.
| Comparison to
Predicate
Device | The technological characteristics of the subject device are identical to
the predicate device. Both devices use the same components and
materials, with the exception of the O-Ring, which has undergone a
material change from silicone to EPDM. Both devices have the same
mode of operation and indications for use. | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Safety &
Performance
Tests | No special controls have been established under Section 514 of the
Food, Drug and Cosmetic Act for these devices. Performance testing
of the subject Rotating Adapters was conducted based on the risk
analysis and based on the requirements of the following international
standards:
ISO 8536-4:2010, Infusion equipment for medical use - Part 4:
Infusion sets for single use, gravity feed ISO 8536-10:2004, Infusion equipment for medical use - Part 10:
Accessories for fluid lines for use with pressure infusion equipment ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products
- routine control of a sterilization process for medical devices ISO 10993-1:2009, Biological Evaluation of Medical Devices Part
1: Evaluation and Testing within a risk management process, and
FDA guidance Required Biocompatibility Training and Toxicology
Profiles for Evaluation of Medical Devices, May 1, 1995 ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical
devices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part
5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices -
Part. 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices -
Part 11: Tests for systemic toxicity ASTM F756-08:2008, Standard Practice for Assessment of
Hemolytic Properties of Materials United States Pharmacopeia 36, National Formulary 31, 2013
Pyrogen Test | |
2
Merit Medical Systems, Inc.
Device Testing
- Merit Rotational Torque Test ●
- . Merit Hydrostatic Pressure Test
- Merit Vacuum Leak Test .
- ISO 8536-4 Chemical Requirements .
- . ISO 8536-10 Particulate
- ISO 8536-10 Leakage .
Biocompatibility
Safety & Performance Tests cont.
- Cytotoxicity · �
- Sensitization .
- Irritation .
- . Systemic Toxicity
- Systemic Injection .
- Pyrogenicity .
- Hemocompatibility : ●
- Chemical Characterization .
The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing, the subject Rotating Adapters meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit Rotator, K932251, manufactured by Merit Medical Systems, Inc ...
3
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
April 16, 2014
Merit Medical Systems, Inc. Mr. Cory Marsh Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, UT 84095 US
Re: K140475
Trade/Device Name: Rotating adapters; male-male, male-female Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold or fitting Regulatory Class: Class II Product Code: DTL Dated: February 24, 2014 Received: February 26, 2014
Dear Mr. Marsh:
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
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and 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 is evenly spaced around the circle.
4
Page 2 - Mr. Cory Marsh
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 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 devicerelated 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" (21 CFR 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/MedicalDeyices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Diseases Office of Evaluation Center for Devices and Radiological Health
Enclosure
5
Merit Medical Systems, Inc.
4.0 Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use: K140475
Merit's Rotating Adapters are indicated for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
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)510(k) Summary
Image /page/5/Picture/14 description: The image shows the text "Bram D. Zuckerman -S 2014.04.16 10:40:19 -04'00'". The text appears to be a timestamp or a record of some kind. The date is April 16, 2014, and the time is 10:40:19. There is also a time zone offset of -04'00'.