Flush Syringe (Prefilled 0.9% normal saline solution)

K231724 · Spm Medicare Pvt. , Ltd. · NGT · Nov 9, 2023 · General Hospital

Device Facts

• Record ID: K231724
• Device Name: Flush Syringe (Prefilled 0.9% normal saline solution)
• Applicant: Spm Medicare Pvt. , Ltd.
• Product Code: NGT · General Hospital
• Decision Date: Nov 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Device Story

Flush Syringe is a sterile, single-use, three-piece polypropylene syringe pre-filled with 0.9% sodium chloride (USP). It features a Luer lock connector and is sealed with a tip cap. Used in clinical settings to flush intravenous administration sets and indwelling access devices. Operation is manual; healthcare providers attach the syringe to the access device and depress the plunger to deliver the saline solution. This process maintains patency of the intravenous line, preventing occlusion and ensuring proper medication delivery. The device is terminally sterilized via gamma radiation.

Clinical Evidence

Bench testing only. Performance testing included physical syringe testing (ISO 7886-1, ISO 11040-8, ISO 80369-7), USP chemical identification and purity testing (pH, particulate matter, extractable metals), and comprehensive biocompatibility testing (ISO 10993 series, including cytotoxicity, sensitization, systemic toxicity, and implantation). Package integrity was verified via ASTM standards (F2338, F88, F1929). Shelf life was validated per ASTM F1980-16.

Technological Characteristics

Materials: Polypropylene (barrel/plunger/tip cap), Bromo Butyl rubber (stopper). Energy: Manual. Connectivity: None. Sterilization: Gamma radiation (10^-6 SAL). Standards: ISO 7886-1, ISO 11040-8, ISO 80369-7, USP <791>, <191>, <788>, <85>, ISO 10993 series, ASTM F2338, F88, F1929, F756-17.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices in patients requiring such maintenance.

Regulatory Classification

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.

Predicate Devices

• Flush Syringe (K183473)

Submission Summary (Full Text)

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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"

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(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 ([e-mail]) or phone [phone] 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

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OHT4: Office of Surgical and Infection Control 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) 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)

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# 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 : [phone] Email:[e-mail]

## Designation Submission

Correspondent Primary Contact Person:

Sanjay Kumar Position: Deputy Manager-QA & MR Tel: [phone] Email : [e-mail]

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

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#### 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.

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| able | 1<br>ﮐﺎ<br>S |
|------|--------------|
| | |

| Device<br>Characteristic | Subject device | Predicate device<br>(K183473) | Discussion |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Indications<br>for<br>Use | The Flush Syringe (Prefilled 0.9%<br>normal saline solution) is intended<br>for use in flushing compatible<br>intravenous administration sets<br>and indwelling intravenous<br>access devices. | The AMSafe 0.9% sodium<br>chloride pre- filled normal<br>saline flush syringe, is<br>intended for use in flushing<br>compatible intravenous<br>administration sets and<br>indwelling intravenous access<br>devices. Use according to the<br>recommend at ions of the<br>manufacturer for the<br>appropriate device. | Identical |
| Operation<br>Principle | The Flush Syringe (Prefilled 0.9%<br>normal saline solution) is a three-<br>piece, sterile, single use syringe<br>with a 6% (Luer) connector pre-<br>filled with 0.9% Sodium Chloride<br>Injection, USP, and sealed with<br>a tip cap. | The AMSafe® Pre- Filled<br>Normal Saline Flush Syringe is<br>a three-piece, sterile, single<br>use syringe with a 6% (Luer)<br>connector pre-filled with 0.9%<br>Sodium Chloride Injection,<br>USP, and sealed with a tip<br>сар. | Identical |
| Design | Flush Syringe (Prefilled 0.9%<br>normal saline solution) with Luer<br>lock connection fitting and non-<br>vented, female Luer lock tip cap | Prefilled Normal Saline plastic<br>piston syringe with Luer lock<br>connection fitting and non-<br>vented, female Luer lock tip<br>cap | Identical |
| Chemical<br>composition | 0.9% Sodium chloride injection,<br>USP | 0.9% Sodium chloride<br>injection, USP | Identical |
| Syringe material | Barrel and plunger:<br>polypropylene<br>Stopper: Bromo Butyl rubber<br>(not made with natural rubber<br>latex)<br>Tip cap: polypropylene with<br>white colorant | Barrel and plunger:<br>polypropylene<br>Stopper: Butyl rubber (not<br>made with natural rubber<br>latex)<br>Tip cap: polypropylene with<br>white colorant | Identical |
| Syringe Size<br>and Fill<br>Volumes | Fill 3ml, 5ml, 10ml volume in<br>10cc syringe | Fill 3ml, 5ml, 10ml volume in<br>12cc syringe<br>Fill 20ml volume in 20cc<br>syringe | Different<br>(Comment 1) |
| Fill Volume<br>Graduation | On syringe label | On syringe label | Identical |
| Syringe Content | 0.9% Sodium Chloride Injection,<br>USP | 0.9% Sodium Chloride<br>Injection, USP | Identical |
| Syringe<br>packaging | Polyster & LD ribbon pouch<br>Sterile barrier | PP wrap or Sterile barrier<br>Plastic peel pouch | Different<br>(Comment 2) |
| Sterile | Yes | Yes | Identical |
| Device with<br>Fluid path only<br>sterile<br>Or<br>Device provided<br>sterile | Device with Fluid path only<br>sterile<br>and<br>Device provided sterile | Device with Fluid path only<br>sterile<br>Or<br>Device provided sterile | Identical |
| Sterilization<br>method and<br>SAL Level | Terminally sterilized by Gamma<br>radiation, 10-6 SAL | Terminally sterilized by<br>Gamma radiation, 10-6 SAL | Similar |
| Labeled non-<br>pyrogenic | Yes | Yes | Identical |
| Single use<br>only | Yes | Yes | Identical |
| Shelf Life | 3 years | 2 years | Different<br>(Comment 3) |
| Content of<br>Syringe<br>Package | One syringe per pouch | One syringe per pouch | Identical |

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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:

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| ID# | Test | Method | Acceptance criteria | Conclusion |
|----------------------------------------|---------------------------------------------------|--------------------------------------------|------------------------------------------------------|-----------------------------|
| 1 | Physical testing of syringe | ISO 7886-1, ISO<br>11040-8, ISO<br>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<br>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<br>Tests | USP<191> | USP<191> | Pass |
| | 0.9% normal saline<br>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<br>metals | USP<233><br>USP<232> | USP<233> USP<232> | Pass |
| | 3 | Particulate matter | USP<788> | ≥10um, ≤6000<br>≥25um, ≤600 |
| | Biocompatibility testing: | | | |
| 4 | Bacterial endotoxins test | USP<85> | Bacterial<br>endotoxins≤0.5EU/mL | Pass |
| | Acute systemic toxicity | ISO10993-11 | No acute systemic<br>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<br>Pyrogenicity | ISO 10993-11 | No pyrogenicity | Pass |
| | Genotoxicity (Bacterial<br>Reverse Mutation Test) | ISO 10993-3 | No Genotoxicity | Pass |
| | Implantation | ISO 10993-6 | No evidence of local<br>tissue effects | Pass |
| | In vitro hemolysis<br>properties | ASTM F756-17 | Non-hemolytic | Pass |
| 5. | Package Integrity Test | | | |
| | Sealing Strength | ASTM F88/F88M and<br>EN 868-5 | Should not be less than<br>1.2N | Pass |
| | Dye Penetration Test | ASTM F 1929 | Should be no evidence of<br>leakage | Pass |
| | Vacuum decay test | ASTM F 2338 | There should be no water<br>present inside the pouch | Pass |

Table 5-2

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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.