Pump Alignment Syringe

K220184 · Jiangsu Caina Medical Co.,Ltd · FMF · Jul 21, 2022 · General Hospital

Device Facts

• Record ID: K220184
• Device Name: Pump Alignment Syringe
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: FMF · General Hospital
• Decision Date: Jul 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

Device Story

Pump Alignment Syringe; piston-style syringe; components: plunger, piston, barrel. Available in 3ml, 5ml, 10ml, 30ml, 60ml volumes; luer-lock or luer-slip connectors. Used by healthcare professionals in clinical settings for controlled fluid delivery via infusion pumps or manual injection. Device provides sterile fluid path; single-use. Benefits include precise fluid administration and compatibility with standard infusion pump systems.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ISO 10993 (biocompatibility: cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis), USP <151> (pyrogen), USP <85> (endotoxins), USP <788> (particulate matter), and ASTM packaging standards (F1929, F88, F1886). Mechanical performance verified per ISO 7886-1, ISO 7886-2, and ISO 80369-7.

Technological Characteristics

Materials: Polypropylene, Polysoprene, Polydimethysiloxane. Piston-style syringe; luer-lock/luer-slip connectors. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 10993-5/7/10/11, ISO 7886-1/2, ISO 80369-7, ASTM F756, ASTM F1929, ASTM F88, ASTM F1886, USP <85>/<151>/<788>.

Indications for Use

Indicated for healthcare professionals to inject fluids into patients of all ages, including neonates, via compatible infusion pumps or manual injection.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Becton Dickinson Single Use Hypodermic Syringes (K980987)

Submission Summary (Full Text)

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July 21, 2022

Jiangsu Caina Medical Co., Ltd. Jianwei Pan Management Representative No.23, Huanxi Road, Zhutang Town Jiangyin, Jiangsu 214415 China

# Re: K220184

Trade/Device Name: Pump Alignment Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 9, 2022 Received: June 22, 2022

# Dear Jianwei Pan:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K220184

Device Name Pump Alignment Syringe

Indications for Use (Describe)

The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <span> <span style="border: 1px solid black; padding: 0px 2px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image shows the logo for CAINA. The logo is blue and green. Below the logo is the website address www.cainamed.com.

# Tab 7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K220184

- 1. Date of Preparation: 06/07/2022
- 2. Sponsor Identification

Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu Position: General Manager Tel: [phone] Fax: [phone] Email: jun.lu(@cainamed.com

- Designated Submission Correspondent 3.
Mr. Jianwei pan (Primary Contact Person) Email: [e-mail] Ms. Tracy Gong (Alternative Contact Person) Email: tracy.gong(@cainamed.com Tel: [phone]-8027 Fax: [phone]-8009

- Identification of Proposed Device 4.
Trade Name: Pump Alignment Syringe

Regulatory Information Classification Name: Piston Syringe Classification: II Product Code:FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital

Indications for Use Statement:

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Image /page/4/Picture/1 description: The image shows the logo for CAINA. The logo is in blue and green. The text "www.cainamed.com" is below the logo.

The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

#### ર. Device Description

The Pump Alignment Syringe is available in various specifications, including 3ml, 5ml, 10ml, 30ml and 60ml. The proposed device consists of three components: (1) plunger, (2) piston, (3) barrel. The connector of barrel have two types of luer-lock and luer-slip.

The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

- న్. Identification of Predicate Device
Predicate Device 510(k) Number: K980987 Product Name: Becton Dickinson Single Use Hypodermic Syringes

- Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- > ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- > ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- > USP <151> Pyrogen Test
- > ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- A ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
- > ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- A ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- A ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- > USP <85> Bacterial Endotoxins Test

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Image /page/5/Picture/1 description: The image shows the word "CAINA" in blue letters with a green triangle in the middle of the "A". Below the word "CAINA" is the website address "www.cainamed.com" in a smaller font. The logo is simple and clean, with the blue and green colors providing a sense of trust and reliability. The website address is easy to read and remember.

- > USP<788> Particulate Matter in Injections
- > ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
- ISO 7886-2:2020 Sterile hypodermic syringe for single use- Part 2: Syringes for use with A power-driven syringe pumps
- > ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7:Connectors for intravascular or hypodermic applications
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device<br>K220184 | Predicate Device<br>K980987 | Comment |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Product code | FMF | FMF | Same |
| Regulation<br>No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Regulation<br>Name | Syringe, Piston | Syringe, Piston | Same |
| Class | II | II | Same |
| Indications<br>for use | The Pump Alignment Syringe<br>is intended for use by<br>healthcare professionals for<br>injection of fluids for medical<br>purposes into patients of all<br>ages, including neonates in a<br>controlled manner with<br>compatible infusion pumps.<br>The Pump Alignment Syringe<br>can also be used for manual<br>injection of fluids for medical<br>purposes. | The BD Single Use,<br>Hypodermic Syringe is<br>intended for use by health<br>care professionals for<br>general purpose fluid<br>aspiration/injection. | Same<br>The 510k<br>summary of<br>K980987 indicates<br>that this device<br>can be used with<br>the infusion pump. |
| Configuration | Piston<br>Plunger<br>Barrel | Piston<br>Plunger<br>Barrel | Same |
| material | Polypropylene,<br>Polysoprene,<br>Polydimethysiloxane | Plastic,<br>Synthetic rubber,<br>Silicone based stopper<br>lubricant | See Comment 1 |
| Sterile | Sterile | Sterile or non-sterile | See Comment 2 |

| | | Table 1 Comparison of Technology Characteristics with K980987 |
|--|--|---------------------------------------------------------------|
| | | |

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Image /page/6/Picture/1 description: The image shows the logo for CAINA. The logo is blue and green. The text below the logo reads "www.cainamed.com".

| Sterile<br>method | EtO Sterilized | EtO or Irradiation<br>sterilization | See Comment 3 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------|
| SAL | 10-6 | 10-6 | Same |
| User group | Healthcare professionals | Healthcare professionals | Same |
| Patient group | All age groups, including<br>neonatal | All age groups, including<br>neonatal | Same |
| Volume | 3ml,5ml,10ml,20ml,30ml,60<br>ml | 1ml,3ml,5ml,10ml,20ml,30<br>ml and 60ml1) | Same |
| Type of use | Prescription only(Rx) | Prescription only(Rx) | Same |
| Single use | Yes | Yes | Same |
| Operation<br>mode | For use with infusion pump<br>or manual use | For use with infusion pump<br>or manual use | Same |
| Label/labeling | Complied with 21 CFR part<br>801 | Complied with 21 CFR part<br>801 | Same |
| Performance<br>Testing | Conform to:<br>ISO 7886-1<br>ISO 7886-2<br>ISO 80369-7 | Conform to:<br>ISO 7886-1<br>ISO 7886-2<br>6% (Luer) connector | Same |
| Biocompatibil<br>ity | Cytotoxicity<br>ISO 10993-5:2009 Third<br>edition<br>Irritation<br>ISO 10993-10:2010 Third<br>edition<br>Sensitization<br>ISO 10993-10:2010 Third<br>edition<br>Acute systemic toxicity<br>ISO 10993-11:2017<br>Third<br>edition<br>Pyrogen<br>USP <151> USP41 NF36<br>Hemolysis<br>ASTM F756-17 Third edition<br>Subacute toxicity<br>ISO 10993-11:2017 Third<br>edition | with ISO 10993 | Same |

Note:1)we infer that these sizes of proposed syringe are covered by the 510(k) number K980987 According to the pump user manual (Medfusion 3500 and Alaris 8015), however, these dimensions do not appear in the summary.

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Image /page/7/Picture/1 description: The image shows the logo for CAINA. The logo is in blue and green. The text "www.cainamed.com" is below the logo.

### Comment 1

Differences in materials between the predicate and subject device were addressed through Biocompatibility Statement and copy of test report.

### Comment 2

The subject device is provided sterile only, the predicate device is provided to include sterile and non-sterile.The difference do not affect safety and effectiveness.

### Comment 3

The sterile method of subject device is Eto only, the sterile method of predicate device include Eto and Irradiation. The difference do not affect safety and effectiveness.

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.