(242 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a stopcock, with no mention of AI or ML.
No
The device is a stopcock used for managing fluid pathways in IV lines and for pressure measurements, not for treating a disease or condition itself.
No
The device is a 3-way stopcock used for infusions, injections, and pressure measurements, primarily for fluid management in venous or arterial lines, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components (Body, Rotating Handle, Luer Ports) and mentions testing related to materials and physical performance, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in managing fluid flow in venous and arterial lines for infusions, injections, and pressure measurements. These are all direct interactions with the patient's circulatory system, not the analysis of samples taken from the body.
- Device Description: The description focuses on the physical components and their function in controlling fluid flow. There is no mention of reagents, sample analysis, or any process that would involve examining biological samples outside of the body.
- Lack of IVD Indicators: The text does not contain any keywords or phrases typically associated with IVD devices, such as "in vitro," "sample analysis," "diagnostic," "assay," "reagent," "laboratory," etc.
- Device Specific Guidance: The device is designed and tested according to guidance for "Intravascular Administration Sets," which are devices used for delivering fluids directly into the bloodstream, not for in vitro diagnostics.
In summary, the device is an accessory used in the administration of fluids and monitoring of pressure within the patient's circulatory system, which falls under the category of medical devices used in vivo, not in vitro.
N/A
Intended Use / Indications for Use
3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions, intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.
Product codes (comma separated list FDA assigned to the subject device)
FMG
Device Description
Three Way Stop cock is composed of a Body, Rotating Handle, Luer Ports – with 2 female luer lock & 1 male luer lock with Rotating Nut. Compatible with 6% Luer combination devices. Transparent, lipid resistant body, provides easy visualization, and indicates fluid path.
The device is designed and tested as per its device specific guidance: "Intravascular Administration Sets Premarket Notification Submissions [510(k)]".
3- Way Stop Cock is used for pressure infusion, for selective running of one or two paths intravenous lines & for measurement & also for monitoring of central venous pressure. 3- Way Stop Cock lipid-resistant is for infusing lipid-fluids & other intravenous fluids. Maximum use duration of the device is not beyond 5 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous or arterial use
Indicated Patient Age Range
Adult & Pediatric
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)
To verify that the Three Way Stop Cock meet the design requirements, testing was conducted in accordance with "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" guidance, ASTM and ISO standards. Risk analysis was carried out in accordance with established in house acceptance criteria based on ISO 14971:2019. Non-clinical performance tests conducted on Three Way Stop Cock are listed in table 5.2.
Biocompatibility tests were performed according to ISO 10993-1:2018 recognized consensus standard and additional parts for each test in conjunction with most current FDA's Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
With respect to raw materials of the subject device, manufacturing agents and processing, no new risks are being introduced. All materials in contact with body tissue or fluids meet ISO 10993. Part 1 "Biological Evaluation of Medical Devices" under the following classification: External Communicating Device Tissue which comes in contact with blood path indirect, prolonged duration (>24 h to 30d).
All test that are required by ISO 10993-1 were performed for the respective endpoints including in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, hemolysis, acute systemic toxicity and repeated dose 28 days toxicity. The biocompatibility tests conducted with respect to these endpoints are listed in table 5.3.
The results of biocompatibility showed that the finished products comply with the requirements of ISO 10993-1 serial standards applicable for Three Way Stop Cock.
The results of the performance testing demonstrate fulfilment of requirements as per device specific guidance "Intravascular Administration Sets Premarket Notifications [510(k)]" guidance as well as substantial equivalence with predicate. The minor differences in the product does not affect the products safety and efficacy.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the words "U.S. FOOD & DRUG ADMINISTRATION" stacked below it.
July 21, 2023
M/s Romsons International Kishore Khanna Partner Unit-II, 9, Noida Special Economic Zone, Noida Dadri Road, Phase - II Noida, Gautam Buddha N Noida, Uttar Pradesh 201305 India
Re: K223499
Trade/Device Name: Three Way Stop Cock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FMG Dated: June 21, 2023 Received: June 21, 2023
Dear Kishore Khanna:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Danil Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223499
Device Name Three Way Stop Cock
Indications for Use (Describe)
3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions. intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.
| Type of Use (Select one or both, as applicable) | |
|---|---|
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Image /page/3/Picture/0 description: The image shows the word "Romsons" in a stylized, green font. The font is cursive and has a flowing, organic feel. There is a registered trademark symbol to the right of the word.
K223499 - 510 (k) Summary
Device Name- Three Way Stop Cock
Submitter Information |21 CFR 807.92(a) (1)] 5.1
M/s Romsons International Unit - II, 9, Noida Special Economic Zone, Noida Dadri Road, Phase - II Noida, Gautam Buddha Nagar, Uttar Pradesh- 201305, India. Tel: +91-5626620000 Ext.213 Fax: +91-5626620089 Website: www.romsons.com Primary Contact: Mr. Kishore Narian Khanna E-mail: imp.reg@romsons.com, kk@romsons.com Secondary Contact: Mr. Saourabh Khanna E-mail: saourabhkhanna@romsons.com, regulatoryl@romsons.com
5.2 Date Prepared
July 21, 2023
5.3 Subject Device [21 CFR 807.92(a) (2)]
| Trade Name: | Three Way Stop Cock |
|---|---|
| Common Name: | IV Set Stopcock |
| Regulation Name: | Intravascular Administrator Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | FMG |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
Predicate Device [21 CFR 807.92(a) (3)] 5.4
K141254; Elcam Medical Stopcocks and manifolds with Safe2 Rotator by Elcam Medical ACAL, Israel.
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Image /page/4/Picture/0 description: The image shows the word "Romsons" in a stylized, cursive font. The word is green and appears to be a logo or brand name. There is a circled R symbol, indicating a registered trademark, to the right of the word.
ર્સ્ડ Device Description [21 CFR 807.92(a) (4)]
Three Way Stop cock is composed of a Body, Rotating Handle, Luer Ports – with 2 female luer lock & 1 male luer lock with Rotating Nut. Compatible with 6% Luer combination devices. Transparent, lipid resistant body, provides easy visualization, and indicates fluid path.
The device is designed and tested as per its device specific guidance: "Intravascular Administration Sets Premarket Notification Submissions [510(k)]".
Image /page/4/Picture/5 description: The image shows a medical three-way stopcock valve on a wooden surface. The valve has three ports, each with a different function. One port is connected to a fluid source, one port is connected to a patient, and the third port is used to control the flow of fluid. The valve is made of clear plastic and has a blue handle. The valve is used to administer fluids to patients in a controlled manner.
Figure 5.1: Three Way Stop Cock
Product Code: GS-3164 Device Name: Three Way Stop Cock
3- Way Stop Cock is used for pressure infusion, for selective running of one or two paths intravenous lines & for measurement & also for monitoring of central venous pressure. 3- Way Stop Cock lipid-resistant is for infusing lipid-fluids & other intravenous fluids. Maximum use duration of the device is not beyond 5 days.
User Profile/Population: Adult & Pediatric
5.6 Indications for Use [21 CFR 807.92(a) (5)]
3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions, intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressurements, flushing with normal saline.
- 5.7 Comparison of the technological characteristics with the predicate device [21 CFR 807.92(a) (6)]
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Image /page/5/Picture/0 description: The image shows the word "Romsons" in a stylized, green font. The font appears to be cursive. There is a circled R symbol to the right of the word.
Traditional 510(k) Premarket Submission.
Three Way Stop Cock
The comparison chart below provides evidence to facilitate the substantial equivalence determination between Three Way Stop Cock and the predicate device (K141254) with respect to the Indications For use, technological characteristics and principles of operation.
| Comparison
parameters | Three Way Stop Cock by M/s
Romsons International
K223499 | Elcam Medical Stopcocks and
manifolds with Safe2 Rotator by
Elcam Medical ACAL
K141254 | Substantial Equivalence
Discussion |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 3-way stopcocks are indicated for
venous or arterial use, as IV add-on
devices used for simultaneous
infusions, intermittent drug
injections, for central venous
pressure measurements, and as
arterial add-on devices used for
invasive pressure measurements,
flushing with normal saline. | Elcam Medical Stopcocks and
manifolds with Safe2 Rotator are
indicated for fluid flow directional
control and for providing access
port(s) for administration of
solutions.
Typical uses include pressure
monitoring, intravenous fluid
administration and transfusion. | Same; even though the
statement is not exactly
the same, the intended use
is the same. |
| Product Code | FMG | FMG | Same |
| Design | Image: Three Way Stop Cock by M/s Romsons International K223499 | Image: Elcam Medical Stopcocks and manifolds with Safe2 Rotator by Elcam Medical ACAL K141254 | Similar, additional Luer
Lock Cap for safety
purpose given to Three
Way Stop Cock by M/s
Romsons International
Performance testing (e.g.,
ISO 80369-7) was
perform to demonstrate
substantial equivalence. |
| Material of
Construction | Body made up of Poly
carbonate/Polysulfone it is lipid
resistance material and rotating
handle is made up of poly ethylene | Body made up of Polycarbonate/
Polysulfone it is lipid resistance
material and rotating handle is made
up of poly ethylene | Similar; biocompatibility
testing was performed to
ensure that the subject
device is as safe and
effective as the predicate. |
| Type of
configuration | 2- Female Luer Lock & 1 – Male
Luer Lock | 2- Female Luer Lock & 1 – Male
Luer Lock | Same |
| 6% Male Luer
Lock Fitting | Proper lock fitting with gauge as per
ISO 80369-7:2021 | Proper lock fitting with gauge as per
ISO 594-2 | Similar; the luer testing is
performed per the updated
ISO standard |
| Comparison
parameters | Three Way Stop Cock by M/s
Romsons International
K223499 | Elcam Medical Stopcocks and
manifolds with Safe2 Rotator by
Elcam Medical ACAL
K141254 | Substantial Equivalence
Discussion |
| 6% Female Luer
Lock Fitting | Proper lock fitting with gauge as per
ISO 80369-7:2021 | Proper lock fitting with gauge as per
ISO 594-1 | Similar; the luer testing is
performed per the updated
ISO standard Similar |
| Colour of Main
Bodv | Clear/ Transparent | Clear/ Transparent | Same |
| Colour of Rotating
Handle | Blue | Blue | Same |
| Colour of Rotating
Luer Lock Nut | Clear/ Transparent | Clear/ Transparent | Same |
| Arrow Indication
on Rotating Handle | Yes | Yes | Same |
| Product
Performance
Specifications | Meets:
ISO 8536-10,
ISO 80369-7,
ISO 80369-20,
ISO 10555-1 | Meets:
ISO 8536-10,
ISO 80369-7,
ISO 80369-20,
ISO 10555-1 | Same |
| Flow rate | As Per ISO 10555-1 | As per ISO 10555-1 | Same |
| Blockage Test | Three Way Stop Cock Connector
Connect with Syringe Luer and
Passes Water | Water easily passes | Same |
| Leakage | No Leakage | No Leakage | Same |
| Biocompatibility | Complies all requirements of ISO
10993-1 | Complies all requirements of ISO
10993-1 | Same |
| Non-Toxic | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization
Method | ETO | ETO | Same |
| Prescription Use | Yes (Rx Only) | Yes (Rx Only) | Same |
Table 5.1. Comparison of Characteristics
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Image /page/6/Picture/0 description: The image shows the word "Romsons" in a green, cursive font. To the right of the word is a small, circular symbol with the letter "R" inside, indicating a registered trademark. The font is bold and slightly italicized, giving the word a dynamic and eye-catching appearance. The overall design is simple yet effective, with the green color providing a sense of freshness and vitality.
Romsons Three Way Stop Cock has similar indications for use statement as the predicate device. The device has similar Design characteristics & same material of construction as the predicate device. Both devices have the same Product Performance Specifications. The results of the performance testing demonstrate substantial equivalence. The minor differences in the product does not affect the products safety and effectiveness.
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Image /page/7/Picture/0 description: The image shows the word "Romsons" in a stylized, green font. The font appears to be a script or cursive style, with flowing lines and rounded edges. A registered trademark symbol is present to the right of the word.
5.8 Performance Data [21 CFR 807.92(b)]: Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b) (1)]
To verify that the Three Way Stop Cock meet the design requirements, testing was conducted in accordance with "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" guidance, ASTM and ISO standards. Risk analysis was carried out in accordance with established in house acceptance criteria based on ISO 14971:2019. Non-clinical performance tests conducted on Three Way Stop Cock are listed in table 5.2.
Biocompatibility tests were performed according to ISO 10993-1:2018 recognized consensus standard and additional parts for each test in conjunction with most current FDA's Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
With respect to raw materials of the subject device, manufacturing agents and processing, no new risks are being introduced. All materials in contact with body tissue or fluids meet ISO 10993. Part 1 "Biological Evaluation of Medical Devices" under the following classification: External Communicating Device Tissue which comes in contact with blood path indirect, prolonged duration (>24 h to 30d).
All test that are required by ISO 10993-1 were performed for the respective endpoints including in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, hemolysis, acute systemic toxicity and repeated dose 28 days toxicity. The biocompatibility tests conducted with respect to these endpoints are listed in table 5.3.
The results of biocompatibility showed that the finished products comply with the requirements of ISO 10993-1 serial standards applicable for Three Way Stop Cock.
The results of the performance testing demonstrate fulfilment of requirements as per device specific guidance "Intravascular Administration Sets Premarket Notifications [510(k)]" guidance as well as substantial equivalence with predicate. The minor differences in the product does not affect the products safety and efficacy.
| Testing Standard | Purpose of the Test |
|---|---|
| ISO 8536-10:2015 | Infusion equipment for medical use |
| ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications |
| ISO 80369-20:2021 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: |
| Common test methods | |
| ISO 10993-4:2017 | Selection of tests for interactions with blood (Hemolysis Test) |
| ISO 10993-5:2009 | Tests for in vitro cytotoxicity |
Table 5.2. Non-Clinical Performance Tests
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Image /page/8/Picture/0 description: The image shows the word "Romsons" in a stylized, green font. The font is cursive and has a flowing, organic feel. There is a registered trademark symbol to the right of the word.
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
|---|---|
| ISO 10993-10:2021 | Biological evaluation of medical devices — Part 10: Tests for skin sensitization |
| ISO 10993-10:2021 | Intracutaneous Reactivity Test |
| ISO 10993-11:2017 | Tests for systemic toxicity |
| USP 2018, Vol.41 | |
| ISO 10993-11:2017 | Material Mediated Pyrogenicity Test |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide |
| ISO 11607-1:2019 | |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ISO 10555-1:2013 | Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements |
| ASTM F 1929-15 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| USP | Particle matter test |
Table 5.3. Biocompatibility Tests
| Testing Standard | Purpose of the Test |
|---|---|
| ISO 10993-4:2017 | Selection of tests for interactions with blood (Hemolysis Test) |
| ISO 10993-5:2009 | Tests for in vitro Cytotoxicity |
| ISO 10993-7:2008 | Biological evaluation of medical devices - Part 7: Ethylene Oxide Sterilization |
| residuals | |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for Skin Sensitization |
| ISO 10993-10:2021 | Intracutaneous Reactivity Test |
| ISO 10993-11:2017 | Tests for Systemic Toxicity |
| ISO 10993-11:2017 | Repeated dose 28-days toxicity test |
| ISO 10993-11:2017 | Material Mediated Pyrogenicity Test |
5.9 Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b) (2)]
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.
5.10 Statement of Substantial Equivalence [21 CFR 807.92(b) (3)]
Romsons Three Way Stop Cock has the similar Indications For use as the predicate device and the device do not raise additional questions of safety and effectiveness.
The conclusion drawn from the non-clinical test demonstrates that Romsons Three Way Stop Cock is as safe and effective and performs similar than the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.