(49 days)
Merit's Rotating Adapters are indicated for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
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
The provided text describes a 510(k) premarket notification for a medical device, the Merit Rotating Adapter. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative testing against standards and the predicate device's characteristics, not on AI model performance or deep learning studies.
Given this context, I cannot fulfill all the requested points (especially those related to AI algorithm performance, human reader improvement with AI, ground truth establishment for AI, or training set details) because the document describes a traditional medical device submission, not an AI/ML medical device submission.
However, I can extract information related to the device's functional and safety testing as described.
Acceptance Criteria and Device Performance for Merit Rotating Adapter (K140475)
The device, Merit Rotating Adapter, is a Class II medical device (Product Code DTL) and is intended for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Merit Rotator, K932251). The performance testing was conducted based on risk analysis and
requirements of international standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list distinct "acceptance criteria values" for each test. Instead, it states that "The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." The tests conducted are listed, implying that passing these tests according to the relevant standards constitutes meeting the acceptance criteria.
| Test Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | - Merit Rotational Torque Test- Merit Hydrostatic Pressure Test- Merit Vacuum Leak Test- ISO 8536-10 Particulate- ISO 8536-10 Leakage | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device." (No specific values or thresholds reported). |
| Chemical | - ISO 8536-4 Chemical Requirements | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device." |
| Biocompatibility | - Cytotoxicity (based on ISO 10993-5:2009)- Sensitization (based on ISO 10993-10:2010)- Irritation (based on ISO 10993-10:2010)- Systemic Toxicity (based on ISO 10993-11:2006)- Systemic Injection (based on ISO 10993-11:2006)- Pyrogenicity (based on USP 36, NF 31, 2013 <151>)- Hemocompatibility (based on ISO 10993-4:2002 (Amd.1:2006) and ASTM F756-08:2008)- Chemical Characterization (based on ISO 10993-1:2009 and FDA guidance) | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device" for all biocompatibility aspects. (No specific results). |
| Sterilization | - ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - routine control of a sterilization process for medical devices) | Test conducted, implies successful meeting of criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (number of units tested) for each of the performance or biocompatibility tests.
Data provenance is not applicable in the context of this device's testing, as it involves physical and chemical tests of the device itself, not data derived from patients or clinical sources. The tests are laboratory-based.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable. The "ground truth" for this type of device (a mechanical adapter) is adherence to engineering and biological safety standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and scientists performing the tests and assessing compliance with the standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical data (e.g., in MRMC studies), which is not the nature of the testing described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. MRMC studies are performed for diagnostic devices (e.g., imaging AI) to assess the impact of a device on human reader performance. This device is a physical adapter for fluid management, not a diagnostic tool requiring human interpretation.
6. Standalone Performance
The "standalone performance" for this device is essentially its ability to meet the specified mechanical, chemical, and biocompatibility standards independently. The document states that "The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." This implies successful standalone performance in the context of the device's function.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is compliance with established international standards (e.g., ISO 8536-4, ISO 8536-10, ISO 10993 series, ASTM F756-08, USP 36) and internal Merit Medical test protocols (Rotational Torque, Hydrostatic Pressure, Vacuum Leak). This is essentially engineering and biomaterial testing standards compliance.
8. Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm or "training set" for this physical medical device.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set mentioned for this type of device.
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Merit Rotating Adapter
Premarket Notification 510(k)
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Merit Medical Systems, Inc.
5.0 510(k) Summary
APR | 6 2014
| GeneralProvisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth 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 | |
| PredicateDevice | 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. | ||
| DeviceDescription | 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 |
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Merit Rotating Adapter
Premarket Notification 510(k)
Merit Medical Systems, Inc.
| Comparison toPredicateDevice | The technological characteristics of the subject device are identical tothe predicate device. Both devices use the same components andmaterials, with the exception of the O-Ring, which has undergone amaterial change from silicone to EPDM. Both devices have the samemode of operation and indications for use. | |
|---|---|---|
| Safety &PerformanceTests | No special controls have been established under Section 514 of theFood, Drug and Cosmetic Act for these devices. Performance testingof the subject Rotating Adapters was conducted based on the riskanalysis and based on the requirements of the following internationalstandards: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 Part1: Evaluation and Testing within a risk management process, andFDA guidance Required Biocompatibility Training and ToxicologyProfiles for Evaluation of Medical Devices, May 1, 1995 ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medicaldevices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part5: 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 ofHemolytic Properties of Materials United States Pharmacopeia 36, National Formulary 31, 2013<151> Pyrogen Test |
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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 ...
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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
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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
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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
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§ 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.