(83 days)
The Merit Manifold with Integrated Transducer is used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The device is also used for measurement of blood pressure.
The Merit Manifold with Integrated Transducer (referred to as M-7 in this submission) is a disposable pressure transducer bonded to a 3-port manifold. The Merit M-T device is a sterile, precalibrated, single-use device used for both a means of interconnecting tubing, catheters, or other devices, and for physiological pressure measurement. A separate reusable interface cable is used with this system to transmit the signal from the transducer to a pressure monitor. The M-T device combines two stand-alone Merit products into a single device, for ease of use and reduction of set-up time.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards/internal protocols) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-1, G95-1, ISO 10993-7 | Met acceptance criteria |
| Sterilization: ISO 11135 | Met acceptance criteria |
| Blood Pressure Transducer Performance: ANSI/AAMI BP 22: 1994[R]2006 | Met acceptance criteria |
| Device Function Verification | Met acceptance criteria |
| Transducer and Compensation Line Verification | Met acceptance criteria |
| Bond Verification | Met acceptance criteria |
| Substantial Equivalence: Based on CDRH's decision tree | Substantially Equivalent to Predicate Devices |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for the test set in any of the verification and validation studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. It only states "in-house protocols" were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish ground truth for any of the performance tests. The studies involved non-clinical performance testing of mechanical and material properties, rather than diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method, as the performance testing was non-clinical and did not involve human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. The device is a physical medical device (fluid manifold with integrated transducer) for physiological pressure measurement, not an AI or diagnostic imaging device that typically undergoes MRMC studies to assess human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not applicable or conducted. This device is a physical instrument, not a software algorithm. The "standalone" performance here refers to the device's own functional and safety performance, which was evaluated through the non-clinical tests listed.
7. The Type of Ground Truth Used
For the non-clinical performance testing (biocompatibility, sterilization, transducer performance, device function, bond verification), the "ground truth" was established by objective measurements against recognized industry standards and internal protocols. For example, for biocompatibility, it's compliance with ISO 10993; for transducer performance, it's compliance with ANSI/AAMI BP 22.
8. The Sample Size for the Training Set
The provided text does not mention or imply the use of a "training set." This is because the device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set was used, this question is not applicable.
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510(k) SUMMARY
GENERAL INFORMATION
Merit Medical Systems, Inc. Submitter Name: 1600 Merit Parkway Address: South Jordan. Utah 84095 Telephone Number: 801-208-4123 (direct) 801-826-4108 (direct) Fax Number: Jeff Carlstrom Contact Person: Date of Preparation: February 2, 2010
DEVICE INFORMATION
Trade or Proprietary Name: Merit Manifold with Integrated Transducer Fluid Manifold; Pressure Transducer Common or Usual Name: Product Code: DTL, DRS Classification Name: Disposable fluid manifold (21 CFR 870.4290) Extravascular blood pressure transducer (21 CFR 870.2850) Classification Panel: Cardiovascular
PREDICATE DEVICE(S)
- Merit Manifold (K913161) .
- Merit Meritrans Disposable Transducer (K920977) .
- Navilyst Perceptor Compensator Morse Manifold (K951722) [combined intended use] .
DEVICE DESCRIPTION
The Merit Manifold with Integrated Transducer (referred to as M-7 in this submission) is a disposable pressure transducer bonded to a 3-port manifold. The Merit M-T device is a sterile, precalibrated, single-use device used for both a means of interconnecting tubing, catheters, or other devices, and for physiological pressure measurement. A separate reusable interface cable is used with this system to transmit the signal from the transducer to a pressure monitor.
The M-T device combines two stand-alone Merit products into a single device, for ease of use and reduction of set-up time.
INTENDED USE
The Merit Manifold with Integrated Transducer is used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other device is also used for measurement of blood pressure.
APR 2 8 2010
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TECHNOLOGICAL COMPARISON
Manifolds and transducers are manually operated devices that provide a user-controlled fluid pathway. The manifold body is composed of polycarbonate, with valves made of Acetal (Delrin''). The transducer package, also made of polycarbonate, is bonded to the manifold using Urethane (Meth) Acrylate blend (Dymax 20163) UV adhesive.
The technological characteristics of the Merit M-T device are identical to those of the Merit predicate devices in terms of intended use, clinical utility and mode of operation, user population, basic design, materials, performance, and sterilization method.
NON-CLINICAL PERFORMANCE TESTING
Verification and validation studies were conducted in accordance with in-house protocols to mitigate risks identified in the clinical risk assessment conducted by Merit. Performance testing was conducted or evaluated based on the following FDA Guidance and industry standards:
- ISO 10993-1: 2003: Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing
- FDA Bluebook memorandum G95-1: Required Biocompatibility Training and Toxicology . Profiles for Evaluation of Medical Devices, May, 1, 1995
- ISO 10993-7: 1995: Biological Evaluation of Medical Devices Part 7: Ethylene Oxide . Sterilization residuals
- ISO 11135: 1994: Medical Devices Validation and routine control of ethylene oxide . sterilization
- ANSI/AAMI BP 22: 1994[R]2006: Blood Pressure Transducers .
Additional Testing not covered by these standards:
- Device Function Verification �
- Transducer and Compensation Line Verification .
- Bond Verification .
Results of performance testing met the acceptance criteria and demonstrate substantial equivalence to the predicate devices.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
Based on CDRH's substantial equivalence decision tree, the Merit Manifold with Integrated Pressure Transducer is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 8 2010
Merit Medical Systems, Inc. c/o Mr. Jeff Carlstrom Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K100319
Trade/Device Name: Merit Manifold with Integrated Transducer Regulatory Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcocks, manifold, or fitting Regulatory Class: II (two) Product Code: DTL, DRS Dated: February 02, 2010 Received: April 23, 2010
Dear Mr. Carlstrom:
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.
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.
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Page 2 - Mr. Jeff Carlstrom
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duna R. Vahner
A Bram D. Zuckerman, M.D. Director
· Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5.0
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Merit Manifold with Integrated Transducer
Indications for Use:
Device Name:
The Merit Manifold with Integrated Transducer is used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The device is also used for measurement of blood pressure.
Prescription Use X (Part 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vaches
(Division Sign-Off) Division of Cardiovascular Devices
KI00319 510(k) Number
Traditional 510(k) Premarket Notification Manifold with Integrated Transducer
Merit Medical Systems, Inc
0025
§ 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.