(242 days)
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.
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.
The provided document is a 510(k) summary for a medical device called "Three Way Stop Cock." This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting a study proving a device meets specific acceptance criteria for AI/ML performance.
The acceptance criteria and study detailed in the document are related to the physical and biological safety and performance of the hardware device, not the performance of an AI/ML algorithm. There is no mention of AI or machine learning in the entire document.
Therefore, I cannot extract the requested information about AI/ML acceptance criteria and a study proving an AI device meets them from this document. The document describes:
- Acceptance Criteria for the hardware device: These are met through compliance with various ISO and ASTM standards covering physical properties (e.g., proper luer lock fitting, flow rate, blockage, leakage) and biocompatibility (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, residuals from sterilization).
- Study that proves the device meets the acceptance criteria (non-clinical testing): The document states that "testing was conducted in accordance with 'Intravascular Administration Sets Premarket Notification Submissions [510(k)]' guidance, ASTM and ISO standards." It lists several specific standards (e.g., ISO 8536-10, ISO 80369-7, ISO 10993 series, ASTM F1980-16, ASTM F 1929-15, USP <788>). The results "demonstrate fulfilment of requirements" and "substantial equivalence with predicate."
The request's specific points regarding AI/ML (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are not applicable to this document as it pertains to a physical medical device (a stopcock valve), not an AI/ML diagnostic or therapeutic device.
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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
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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
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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.
| Comparisonparameters | Three Way Stop Cock by M/sRomsons InternationalK223499 | Elcam Medical Stopcocks andmanifolds with Safe2 Rotator byElcam Medical ACALK141254 | Substantial EquivalenceDiscussion |
|---|---|---|---|
| Indications for Use | 3-way stopcocks are indicated forvenous or arterial use, as IV add-ondevices used for simultaneousinfusions, intermittent druginjections, for central venouspressure measurements, and asarterial add-on devices used forinvasive pressure measurements,flushing with normal saline. | Elcam Medical Stopcocks andmanifolds with Safe2 Rotator areindicated for fluid flow directionalcontrol and for providing accessport(s) for administration ofsolutions.Typical uses include pressuremonitoring, intravenous fluidadministration and transfusion. | Same; even though thestatement is not exactlythe same, the intended useis 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 LuerLock Cap for safetypurpose given to ThreeWay Stop Cock by M/sRomsons InternationalPerformance testing (e.g.,ISO 80369-7) wasperform to demonstratesubstantial equivalence. |
| Material ofConstruction | Body made up of Polycarbonate/Polysulfone it is lipidresistance material and rotatinghandle is made up of poly ethylene | Body made up of Polycarbonate/Polysulfone it is lipid resistancematerial and rotating handle is madeup of poly ethylene | Similar; biocompatibilitytesting was performed toensure that the subjectdevice is as safe andeffective as the predicate. |
| Type ofconfiguration | 2- Female Luer Lock & 1 – MaleLuer Lock | 2- Female Luer Lock & 1 – MaleLuer Lock | Same |
| 6% Male LuerLock Fitting | Proper lock fitting with gauge as perISO 80369-7:2021 | Proper lock fitting with gauge as perISO 594-2 | Similar; the luer testing isperformed per the updatedISO standard |
| Comparisonparameters | Three Way Stop Cock by M/sRomsons InternationalK223499 | Elcam Medical Stopcocks andmanifolds with Safe2 Rotator byElcam Medical ACALK141254 | Substantial EquivalenceDiscussion |
| 6% Female LuerLock Fitting | Proper lock fitting with gauge as perISO 80369-7:2021 | Proper lock fitting with gauge as perISO 594-1 | Similar; the luer testing isperformed per the updatedISO standard Similar |
| Colour of MainBodv | Clear/ Transparent | Clear/ Transparent | Same |
| Colour of RotatingHandle | Blue | Blue | Same |
| Colour of RotatingLuer Lock Nut | Clear/ Transparent | Clear/ Transparent | Same |
| Arrow Indicationon Rotating Handle | Yes | Yes | Same |
| ProductPerformanceSpecifications | 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 ConnectorConnect with Syringe Luer andPasses Water | Water easily passes | Same |
| Leakage | No Leakage | No Leakage | Same |
| Biocompatibility | Complies all requirements of ISO10993-1 | Complies all requirements of ISO10993-1 | Same |
| Non-Toxic | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| SterilizationMethod | 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 <788> | 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 Sterilizationresiduals |
| 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.
§ 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.