K Number
K220184
Device Name
Pump Alignment Syringe
Date Cleared
2022-07-21

(178 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

Not Found

No
The device description and performance studies focus on the physical components and standard testing of a syringe, with no mention of AI or ML capabilities.

No
The device is a syringe used for controlled or manual injection of fluids, which is a delivery mechanism, not a therapeutic agent itself.

No
The device, a Pump Alignment Syringe, is intended for the injection of fluids for medical purposes, not for diagnosing medical conditions. Its function is to deliver substances, not to identify or evaluate diseases.

No

The device description clearly outlines physical components (plunger, piston, barrel) and manufacturing processes (sterilization), indicating it is a hardware medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the injection of fluids into patients for medical purposes. This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism) diagnostic test.
  • Device Description: The device is a syringe, which is a tool for administering substances to a patient. It does not perform any diagnostic testing on biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FMF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

All ages, including neonates

Intended User / Care Setting

Healthcare professionals

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)

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 Pyrogen Test
  • ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
  • 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.
  • ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
  • ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
  • USP Bacterial Endotoxins Test
  • USP 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 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

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.

K980987

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

§ 880.5860 Piston syringe.

(a)
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.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)
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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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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
    1. 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: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu(@cainamed.com

  • Designated Submission Correspondent 3.
    Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Tracy Gong (Alternative Contact Person) Email: tracy.gong(@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009

  • 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 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 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 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

    1. Clinical Test Conclusion

No clinical study is included in this submission.

  • Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device
K220184 | Predicate Device
K980987 | Comment |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Product code | FMF | FMF | Same |
| Regulation
No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Regulation
Name | Syringe, Piston | Syringe, Piston | Same |
| Class | II | II | Same |
| 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. | The BD Single Use,
Hypodermic Syringe is
intended for use by health
care professionals for
general purpose fluid
aspiration/injection. | Same
The 510k
summary of
K980987 indicates
that this device
can be used with
the infusion pump. |
| Configuration | Piston
Plunger
Barrel | Piston
Plunger
Barrel | Same |
| material | Polypropylene,
Polysoprene,
Polydimethysiloxane | Plastic,
Synthetic rubber,
Silicone based stopper
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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| Sterile
method | EtO Sterilized | EtO or Irradiation
sterilization | See Comment 3 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------|
| SAL | 10-6 | 10-6 | Same |
| User group | Healthcare professionals | Healthcare professionals | Same |
| Patient group | All age groups, including
neonatal | All age groups, including
neonatal | Same |
| Volume | 3ml,5ml,10ml,20ml,30ml,60
ml | 1ml,3ml,5ml,10ml,20ml,30
ml and 60ml1) | Same |
| Type of use | Prescription only(Rx) | Prescription only(Rx) | Same |
| Single use | Yes | Yes | Same |
| Operation
mode | For use with infusion pump
or manual use | For use with infusion pump
or manual use | Same |
| Label/labeling | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | Same |
| Performance
Testing | Conform to:
ISO 7886-1
ISO 7886-2
ISO 80369-7 | Conform to:
ISO 7886-1
ISO 7886-2
6% (Luer) connector | Same |
| Biocompatibil
ity | Cytotoxicity
ISO 10993-5:2009 Third
edition
Irritation
ISO 10993-10:2010 Third
edition
Sensitization
ISO 10993-10:2010 Third
edition
Acute systemic toxicity
ISO 10993-11:2017
Third
edition
Pyrogen
USP USP41 NF36
Hemolysis
ASTM F756-17 Third edition
Subacute toxicity
ISO 10993-11:2017 Third
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.

    1. 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.