(149 days)
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
The provided document describes the acceptance criteria and a summary of non-clinical testing for the "Flush Syringe (Prefilled 0.9% normal saline solution)". This is a medical device, and the testing outlined is for its safety and performance, not for an AI model. Therefore, many of the requested fields related to AI/algorithm performance (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) are not applicable.
Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the study proving it:
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1. Physical testing of syringe | ||||
| Physical testing of syringe | ISO 7886-1, ISO 11040-8, ISO 80369-7 | ISO7886-1 ISO80369-7 | Pass | |
| Integrity test of package | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO 80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringe test | ISO 7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO 7886-1 | ISO7886-1 | Pass | |
| Limits of acidity or alkalinity of syringe | ISO 7886-1 | ISO7886-1 | Pass | |
| Sodium Chloride Injection, USP Testing | ||||
| pH value | USP<791> | PH: 4.5-7.0 | Pass | |
| Chemical Identification Tests | USP<191> | USP<191> | Pass | |
| 0.9% normal saline content test | USP 6-466 | 0.86% - 0.94% | Pass | |
| Oxidizable substance test | VP200 | VP200 | Pass | |
| 2. | Iron test | USP<241> | <2ppm | Pass |
| Ammonium | USP<191> | USP<191> | Pass | |
| Calcium | USP<191> | USP<191> | Pass | |
| Carbonate | USP<191> | USP<191> | Pass | |
| Sulfate | USP<191> | USP<191> | Pass | |
| Total organic carbon | USP<643> | USP<643> | Pass | |
| Limits of extractable metals | USP<233> USP<232> | USP<233> USP<232> | Pass | |
| 3. | Particulate matter | USP<788> | ≥10um, ≤6000 ≥25um, ≤600 | Pass |
| 4. Biocompatibility testing: | ||||
| Bacterial endotoxins test | USP<85> | Bacterial endotoxins≤0.5EU/mL | Pass | |
| Acute systemic toxicity | ISO10993-11 | No acute systemic toxicity | Pass | |
| Intra-cutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| Material Mediated Pyrogenicity | ISO 10993-11 | No pyrogenicity | Pass | |
| Genotoxicity (Bacterial Reverse Mutation Test) | ISO 10993-3 | No Genotoxicity | Pass | |
| Implantation | ISO 10993-6 | No evidence of local tissue effects | Pass | |
| In vitro hemolysis properties | ASTM F756-17 | Non-hemolytic | Pass | |
| 5. Package Integrity Test | ||||
| Sealing Strength | ASTM F88/F88M and EN 868-5 | Should not be less than 1.2N | Pass | |
| Dye Penetration Test | ASTM F 1929 | Should be no evidence of leakage | Pass | |
| Vacuum decay test | ASTM F 2338 | There should be no water present inside the pouch | Pass | |
| Shelf Life | Shelf life evaluation | ASTM F1980-16 | Device within specification for 3 years | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each test conducted. It only lists the tests performed, the methods used, and the acceptance criteria. The provenance of the samples (e.g., country of origin, retrospective/prospective) is also not mentioned. These tests are laboratory-based non-clinical tests rather than studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device, and the performance testing is based on established international and national standards and laboratory methods, not expert interpretation of outputs like in AI/CAD systems.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI model evaluations, not for the direct physical and chemical testing of a sterile medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for the premarket notification of a physical medical device (flush syringe), not an AI or CAD system. Thus, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by adherence to recognized consensus standards and validated chemical/physical testing methods (e.g., ISO, ASTM, USP). The acceptance criteria for each test (e.g., pH range, bacterial endotoxin limits, physical strength) serve as the objective ground truth.
8. The sample size for the training set
Not applicable. This device is not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2023
SPM Medicare Pvt. Ltd. Sanjay Kumar Deputy Manager B-40. Phase II Noida, Gautam Budh Nagar, Uttar Pradesh 201305 India
Re: K231724
Trade/Device Name: Flush Syringe (Prefilled 0.9% normal saline solution) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: June 13, 2023 Received: June 13, 2023
Dear Sanjay Kumar:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
{2}------------------------------------------------
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K231724
Device Name
Flush Syringe (Prefilled 0.9% normal saline solution)
Indications for Use (Describe)
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Summary K231724
This 510K summary is being prepared in accordance with the requirements of Title 21, CFR Section 807.92.
a) Submitter Information:
- : SPM Medicare Pvt. Ltd Submitter B-40,Phase II Gautam Budh Nagar Noida -201305,Uttar Pradesh, India
- Mr. Umang Mathur Contact Person: Position :Managing Director Tel : +91-971-100-8401 Email:umang@spmmedicare.com
Designation Submission
Correspondent Primary Contact Person:
Sanjay Kumar Position: Deputy Manager-QA & MR Tel: +91-8384011434 Email : sanjay.qa@spmmedicare.com
Date of Preparation : 11-08-2023
b) Device Information:
Trade or Proprietary Name: Common or Usual Name: Classification Name: Product Code: Regulation Number: Device Classification: Review Panel:
Flush Syringe (Prefilled 0.9% normal saline solution) Pre-Filled Normal Saline Flush Syringe Saline, vascular access flush NGT 880.5200 General Hospital
{5}------------------------------------------------
Identification of Legally Marketed Device(s): c)
Flush Syringe, 510K number K183473.
d) Device Description:
Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
Indications for Use: e)
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Technological Characteristics Comparison: f)
Intended use: The subject device has the same intended use as the predicate device.
Comparison between subject device and predicate device.
{6}------------------------------------------------
| able | 1ﮐﺎS |
|---|---|
| DeviceCharacteristic | Subject device | Predicate device(K183473) | Discussion |
|---|---|---|---|
| IndicationsforUse | The Flush Syringe (Prefilled 0.9%normal saline solution) is intendedfor use in flushing compatibleintravenous administration setsand indwelling intravenousaccess devices. | The AMSafe 0.9% sodiumchloride pre- filled normalsaline flush syringe, isintended for use in flushingcompatible intravenousadministration sets andindwelling intravenous accessdevices. Use according to therecommend at ions of themanufacturer for theappropriate device. | Identical |
| OperationPrinciple | The Flush Syringe (Prefilled 0.9%normal saline solution) is a three-piece, sterile, single use syringewith a 6% (Luer) connector pre-filled with 0.9% Sodium ChlorideInjection, USP, and sealed witha tip cap. | The AMSafe® Pre- FilledNormal Saline Flush Syringe isa three-piece, sterile, singleuse syringe with a 6% (Luer)connector pre-filled with 0.9%Sodium Chloride Injection,USP, and sealed with a tipсар. | Identical |
| Design | Flush Syringe (Prefilled 0.9%normal saline solution) with Luerlock connection fitting and non-vented, female Luer lock tip cap | Prefilled Normal Saline plasticpiston syringe with Luer lockconnection fitting and non-vented, female Luer lock tipcap | Identical |
| Chemicalcomposition | 0.9% Sodium chloride injection,USP | 0.9% Sodium chlorideinjection, USP | Identical |
| Syringe material | Barrel and plunger:polypropyleneStopper: Bromo Butyl rubber(not made with natural rubberlatex)Tip cap: polypropylene withwhite colorant | Barrel and plunger:polypropyleneStopper: Butyl rubber (notmade with natural rubberlatex)Tip cap: polypropylene withwhite colorant | Identical |
| Syringe Sizeand FillVolumes | Fill 3ml, 5ml, 10ml volume in10cc syringe | Fill 3ml, 5ml, 10ml volume in12cc syringeFill 20ml volume in 20ccsyringe | Different(Comment 1) |
| Fill VolumeGraduation | On syringe label | On syringe label | Identical |
| Syringe Content | 0.9% Sodium Chloride Injection,USP | 0.9% Sodium ChlorideInjection, USP | Identical |
| Syringepackaging | Polyster & LD ribbon pouchSterile barrier | PP wrap or Sterile barrierPlastic peel pouch | Different(Comment 2) |
| Sterile | Yes | Yes | Identical |
| Device withFluid path onlysterileOrDevice providedsterile | Device with Fluid path onlysterileandDevice provided sterile | Device with Fluid path onlysterileOrDevice provided sterile | Identical |
| Sterilizationmethod andSAL Level | Terminally sterilized by Gammaradiation, 10-6 SAL | Terminally sterilized byGamma radiation, 10-6 SAL | Similar |
| Labeled non-pyrogenic | Yes | Yes | Identical |
| Single useonly | Yes | Yes | Identical |
| Shelf Life | 3 years | 2 years | Different(Comment 3) |
| Content ofSyringePackage | One syringe per pouch | One syringe per pouch | Identical |
{7}------------------------------------------------
Comment 1: The subject device has range 3ml, 5ml & 10 ml which is similar to predicate device, predicate device has additionally Fill 20ml volume in 20cc syringe, the device capacity is based on device intended use, it does not impact intended use. Fill volume according to the market needs.
Comment 2: Subjective device has different pouch packing with comparison of predicate device, package integrity tests is conducted, different pack size does not impact on intended usage of product.
Comment 3: Subjective device has 3 years shelf life while predicate device has 2 years; stability study is conducted to justify the shelf life. It does not impact the intended usage and product Quality.
g) Summary of Non-clinical Testing (Bench):
The non-clinical testing for Flush Syringe (Prefilled 0.9% normal saline solution) was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
The following performance testing was conducted on the proposed device:
{8}------------------------------------------------
| ID# | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing of syringe | ISO 7886-1, ISO11040-8, ISO80369-7 | ISO7886-1 ISO80369-7 | Pass |
| Integrity test of package | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO 80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringe test | ISO 7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO 7886-1 | ISO7886-1 | Pass | |
| Limits of acidity oralkalinity of syringe | ISO 7886-1 | ISO7886-1 | Pass | |
| Sodium Chloride Injection, USP Testing | ||||
| pH value | USP<791> | PH: 4.5-7.0 | Pass | |
| Chemical IdentificationTests | USP<191> | USP<191> | Pass | |
| 0.9% normal salinecontent test | USP 6-466 | 0.86% - 0.94% | Pass | |
| Oxidizable substance test | VP200 | VP200 | Pass | |
| 2 | Iron test | USP<241> | <2ppm | Pass |
| Ammonium | USP<191> | USP<191> | Pass | |
| Calcium | USP<191> | USP<191> | Pass | |
| Carbonate | USP<191> | USP<191> | Pass | |
| Sulfate | USP<191> | USP<191> | Pass | |
| Total organic carbon | USP<643> | USP<643> | Pass | |
| Limits of extractablemetals | USP<233>USP<232> | USP<233> USP<232> | Pass | |
| 3 | Particulate matter | USP<788> | ≥10um, ≤6000≥25um, ≤600 | |
| Biocompatibility testing: | ||||
| 4 | Bacterial endotoxins test | USP<85> | Bacterialendotoxins≤0.5EU/mL | Pass |
| Acute systemic toxicity | ISO10993-11 | No acute systemictoxicity | Pass | |
| Intra-cutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| Material MediatedPyrogenicity | ISO 10993-11 | No pyrogenicity | Pass | |
| Genotoxicity (BacterialReverse Mutation Test) | ISO 10993-3 | No Genotoxicity | Pass | |
| Implantation | ISO 10993-6 | No evidence of localtissue effects | Pass | |
| In vitro hemolysisproperties | ASTM F756-17 | Non-hemolytic | Pass | |
| 5. | Package Integrity Test | |||
| Sealing Strength | ASTM F88/F88M andEN 868-5 | Should not be less than1.2N | Pass | |
| Dye Penetration Test | ASTM F 1929 | Should be no evidence ofleakage | Pass | |
| Vacuum decay test | ASTM F 2338 | There should be no waterpresent inside the pouch | Pass |
Table 5-2
{9}------------------------------------------------
The shelf life of the final finished sterilized device was evaluated according to the recognized consensus standard ASTM F1980-16 to verify that the subject device will remain within specification during the prescribed shelf life when stored under the labeled storage conditions.
h) Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the Flush Syringe (Prefilled 0.9% normal saline solution) is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).