Safety Sliding Blood Collection Set

K232781 · Jiangsu Caina Medical Co.,Ltd · JKA · Mar 7, 2024 · Clinical Chemistry

Device Facts

• Record ID: K232781
• Device Name: Safety Sliding Blood Collection Set
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: JKA · Clinical Chemistry
• Decision Date: Mar 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Safety Sliding Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

Device Story

Device is a sterile, single-use blood collection set with an active safety feature to prevent accidental needle sticks. It consists of a needle, butterfly wings, flexible tubing, and optional holder/adapter configurations. Operated by trained medical professionals in healthcare facilities; device is inserted into a patient's vascular system. Blood flows into a vacuum collection tube via differential pressure. The active safety mechanism is manually activated by the user, providing an audible click upon engagement. The device aids in safe blood specimen collection and short-term IV fluid administration, reducing the risk of sharps injuries to healthcare personnel.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, including biocompatibility (ISO 10993 series), sterility, packaging integrity (ASTM F1929, F88), and mechanical performance (ISO 80369, ISO 8536-4, ISO 9626, ISO 7864). Sharps injury protection verified per ISO 23908.

Technological Characteristics

Materials: Stainless steel (SUS304), PVC, ABS, MABS, Isoprene Rubber, Polydimethylsiloxane. Features: Active manual safety shield with audible click. Configurations: Various needle gauges (20G-25G) and tube lengths (10cm-30cm). Sterilization: Ethylene Oxide (EtO) to SAL 10^-6. Standards: ISO 10993, ISO 80369-7/20, ISO 8536-4, ISO 9626, ISO 7864, ISO 23908.

Indications for Use

Indicated for patients requiring blood collection or short-term (up to 2 hours) IV fluid administration. Used by trained medical professionals in healthcare facilities.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set (K980414)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 7, 2024

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

Re: K232781

Trade/Device Name: Safety Sliding Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: January 12, 2024 Received: February 5, 2024

Dear Camel Zhou:

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.

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,

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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) K232781

Device Name Safety Sliding Blood Collection Set

## Indications for Use (Describe)

The Safety Sliding Blood Collection Set is intention into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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# K232781- 510(k) Summary

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

- 1. Date of Preparation: March 7, 2024
- 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: [e-mail]

#### 3. Designated Submission Correspondent

Mr. Camel Zhou (Primary Contact Person) Email: [e-mail] Ms. Tracy Gong (Alternative Contact Person) Email: [e-mail] Tel: [phone]-8027 Fax: [phone]-8009

- Identification of Subject Device 4.
Trade Name: Safety Sliding Blood Collection Set Common name: Blood Collection Set Regulation Name: Blood specimen collection device Device Class: Class II Product Code: JKA Regulation Number: 21 CFR 862.1675

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Image /page/5/Picture/0 description: The image shows the word "CAINA" in blue, with a green triangle in the middle of the A's. Below the word is the website address "www.cainamed.com" in a smaller font. The logo is simple and clean, with the blue and green colors giving it a professional look. The website address indicates that the company is likely related to the medical field.

#### న. Identification of Predicate Device

Predicate Device 510(k) Number: K980414 Product Name: VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set Regulation Name: Blood specimen collection device Device Class: Class II Product Code: JKA Regulation Number: 21 CFR 862.1675

- 6. Indications for Use Statement:
The Safety Sliding Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

- 7. Device Description
Components of the subject device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap.

The subject device has three configurations: with Holder, with Holder, without Male Adapter. Each configuration has all of the (1) - (6) components mentioned above. The difference between the three configurations is that they have only one or more of the (7) – (12) components mentioned above. The proposed device is available various needle size and flexible tube length. The range of needle size is from 25G (0.5mm) to 20G (0.9mm). The range of flexible tube length is from 10cm (4"). Detailed information was listed as below:

| Configuration | Needle gauge | Needle length | Flexible tube<br>length | Male adapter | Holder |
|-------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------|--------|
| without<br>Holder | 25G(0.5mm);<br>Thin-walled | 1/2"(13mm) | 4"(10cm) | Yes | No |
| | | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | 1/2"(13mm) | 7"(18cm) | | | |
| | 5/8"(16mm) | 7"(18cm) | | | |
| | 3/4"(20mm) | 7"(18cm) | | | |
| | 1/2"(13mm) | 12"(30cm) | | | |
| | 5/8"(16mm) | 12"(30cm) | | | |
| | 3/4"(20mm) | 12"(30cm) | | | |
| | 23G(0.6mm);<br>Thin-walled | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | | | | |
| | 22G(0.7mm);<br>Thin-walled | 3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm) | 12"(30cm)<br>4"(10cm)<br>4"(10cm)<br>7"(18cm)<br>7"(18cm)<br>12"(30cm)<br>12"(30cm) | | |
| | 21G(0.8mm);<br>Thin-walled | 5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm) | 4"(10cm)<br>4"(10cm)<br>7"(18cm)<br>7"(18cm)<br>12"(30cm)<br>12"(30cm) | | |
| | 20G(0.9mm);<br>Thin-walled | 5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm) | 4"(10cm)<br>4"(10cm)<br>7"(18cm)<br>7"(18cm)<br>12"(30cm)<br>12"(30cm) | | |
| with<br>Holder | 25G(0.5mm);<br>Thin-walled | 1/2"(13mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>1/2"(13mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>1/2"(13mm)<br>5/8"(16mm)<br>3/4"(20mm) | 4"(10cm)<br>4"(10cm)<br>4"(10cm)<br>7"(18cm)<br>7"(18cm)<br>7"(18cm)<br>12"(30cm)<br>12"(30cm)<br>12"(30cm) | Yes | Yes |
| | 23G(0.6mm);<br>Thin-walled | 5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm) | 4"(10cm)<br>4"(10cm)<br>7"(18cm)<br>7"(18cm)<br>12"(30cm)<br>12"(30cm) | | |
| | 22G(0.7mm);<br>Thin-walled | 5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm)<br>5/8"(16mm)<br>3/4"(20mm) | 4"(10cm)<br>4"(10cm)<br>7"(18cm)<br>7"(18cm)<br>12"(30cm)<br>12"(30cm) | | |
| | | | | | |
| | Thin-walled | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | 3/4"(20mm) | 12"(30cm) | | |
| | 20G(0.9mm); | 5/8"(16mm) | 4"(10cm) | | |
| | Thin-walled | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | 3/4"(20mm) | 12"(30cm) | | |
| without<br>Male Adapter | 25G(0.5mm);<br>Thin-walled | 1/2"(13mm) | 4"(10cm) | No | No |
| | | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | | 1/2"(13mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 1/2"(13mm) | 12"(30cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | 3/4"(20mm) | 12"(30cm) | | |
| | 23G(0.6mm);<br>Thin-walled | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | 3/4"(20mm) | 12"(30cm) | | |
| | 22G(0.7mm);<br>Thin-walled | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | 3/4"(20mm) | 12"(30cm) | | |
| | 21G(0.8mm);<br>Thin-walled | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |
| | | 3/4"(20mm) | 7"(18cm) | | |
| | | 5/8"(16mm) | 12"(30cm) | | |
| | | 3/4"(20mm) | 12"(30cm) | | |
| | 20G(0.9mm);<br>Thin-walled | 5/8"(16mm) | 4"(10cm) | | |
| | | 3/4"(20mm) | 4"(10cm) | | |
| | | 5/8"(16mm) | 7"(18cm) | | |

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Image /page/6/Picture/0 description: The image shows the logo for CAINA. The logo is in blue and green. The text "www.cainamed.com" is below the logo.

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Image /page/7/Picture/0 description: The image shows the logo for CAINA. The logo is in blue and green. The text "CAINA" is in blue, with a green triangle in the middle of the "A"s. Below the text is the website address "www.cainamed.com".

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Image /page/8/Picture/0 description: The image shows the word "CAINA" in large, blue, sans-serif letters. A green triangle is placed in the middle of the word, between the "I" and the "N". Below the word "CAINA", the text "www.cainamed.com" is written in a smaller font. The logo appears to be for a company called "CAINA" with the website "www.cainamed.com".

| 3/4"(20mm) | 7"(18cm) |
|------------|-----------|
| 5/8"(16mm) | 12"(30cm) |
| 3/4"(20mm) | 12"(30cm) |

The subject device has sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature.

The subject device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

#### Substantially Equivalent (SE) Comparison 8.

| Characteristic | Subject Device, K232781 | Predicate Device, K980414 | SE Discussion |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indications for use | The Safety Sliding Blood<br>Collection Set is intended to be<br>used for insertion into a<br>patient's vascular system for<br>blood collection or short term<br>(up to 2 hours) IV<br>administration, by a trained<br>medical professional. It aids in<br>the prevention of accidental<br>needle stick through the use of<br>an active safety feature | The Vacutainer Brand Blood<br>Collection Set and Safety-Lok<br>Blood Collection Set is a winged<br>blood collection needle and<br>flexible tubing for venipuncture<br>to collect blood specimen from<br>patients or monitoring blood<br>pressure. The Safety-Lok Blood<br>Collection Set also contains a<br>needle safety shield which<br>minimizes the possibility of a<br>needlesticks if manually<br>activated following blood<br>collection. The Vacutainer<br>Brand Blood Collection Set and<br>Safety-Lok Blood Collection Set<br>is also recommended for use in<br>patients with small veins.<br>The Vacutainer Brand Blood<br>Collection Sets and Safety-Lok<br>Blood is also indicated for the<br>intravenous administration of<br>fluids and may be used for any | Similar<br>See Comment 1 |
| | | | |
| | | consideration given to patient<br>size, appropriateness for the<br>solution being infused and<br>duration of therapy. | |
| Components | Needle cap<br>Butterfly wings<br>Safety shield<br>Needle<br>Flexible tube<br>Female luer (adapter)<br>Male luer hub<br>Puncture needle<br>Rubber sleeve<br>Puncture needle protect cover<br>Holder<br>Protective cap | Needle cap<br>Butterfly wings<br>Safety shield<br>Needle<br>Flexible tube<br>Female luer (adapter)<br>Male luer hub<br>Puncture needle<br>Rubber sleeve<br>Holder<br>Protective cap | Different<br>See Comment 2 |
| Patient<br>contact<br>material | Stainless steel SUS304;<br>Polyvinyl chloride (PVC);<br>Acrylonitrile butadiene styrene<br>plastics(ABS);<br>Methyl methacrylate<br>acrylonitrile butadiene styrene<br>plastics(MABS);<br>Isoprene Rubber;<br>Polydimethysiloxane;<br>Color additive. | unknown | Different<br>See Comment 3 |
| Conditions of<br>Use | Used in a health care facility by<br>trained medical professional. | Used in a health care facility by<br>trained medical professional. | Same |
| Needle size | Needle gauge 20G, 21G, 22G,<br>23G, 25G<br>Needle length 1/2", 5/8", 3/4" | Needle gauge 21G,23G, 25G<br>Needle length 3/4" | Different<br>See Comment 4 |
| Tube length | 10cm(4"), 18cm(7"),<br>30cm(12") | 12" | Different<br>See Comment 4 |
| Colors of safety<br>shield | Translucent yellow | Translucent yellow | same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Sterile | Yes | Yes | Same |
| Sterilization<br>Method | EO | EO | Same |
| Sterility<br>Assurance Level | 10-6 | 10-6 | Same |
| Non Pyrogenic | Yes | Yes | Same |
| Shelf life | 3 years | 3 years | Same |
| Single use | Yes | Yes | Same |
| Prescription<br>Only or OTC | Prescription only | Prescription only | Same |
| Principles of<br>operation | When vacuum blood collection tube is used, blood flows into the blood collection tube via the device under the action of differential pressure. | When vacuum blood collection tube is used, blood flows into the blood collection tube via the device under the action of differential pressure. | Same |
| Safety feature | Manual, active safety feature, an audible click indicate activation of safety feature | Manual, active safety feature, an audible click indicate activation of safety feature | Same |

Table 1 Comparison of Technology Characteristics

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Image /page/9/Picture/0 description: The image shows the logo for CAINA. The logo is in blue and green. The text "www.cainamed.com" is below the logo.

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Image /page/10/Picture/0 description: The image shows the word "CAINA" in blue, with a green triangle in the middle of the "A". Below the word "CAINA" is the website address "www.cainamed.com". The text is in a sans-serif font and is easy to read. The overall impression is one of a clean and professional logo.

## Comment 1

The subject device indications for use are similar to the predicate device indications for use. Both the subject and predicate devices are indicated for blood collection and IV administration. The difference is the subject device indication for use includes the maximum time for which the device can be used for IV administration, which is 2 hours. The difference does not raise different questions of safety and effectiveness.

## Comment 2

The subject device provides an additional puncture needle protection cover compared to the predicate device. The puncture needle protect cover is made of PP, which is designed to prevent from needle stick injuries. The difference does not raise different questions of safety and effectiveness.

### Comment 3

The patient contact materials for the subject device are different from predicate device. According to FDA guidance, Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the subject device is an externally communicating device of Blood path, indirect and limited contact. The Cytotoxicity test, Intracutaneous reactivity test, Acute systemic toxicity test, Hemolysis test have been performed for subject device and adequately demonstrated biocompatibility. Therefore, this material difference does not affect substantially equivalence on safety and effectiveness.

### Comment 4

The needle size and flexible tube length is different between subject device and predicate device. The subject device includes additional device configurations that include additional needle gauges and lengths and flexible tubing lengths. These additional devices configurations have been verified according to ISO 9626, ISO 7864, ISO 8536-4. The differences do not raise different questions of safety and effectiveness.

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Image /page/11/Picture/0 description: The image shows the word "CAINA" in large, blue, sans-serif font. There is a small green triangle at the bottom of the letters "A" and "I". Below the word "CAINA" is the website address "www.cainamed.com" in a smaller font.

#### 9. Non-Clinical Testing

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

- > ISO 10993-7:2008 AMD.1:2019 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 A cytotoxicity
- A ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation A
- > ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicitv
- > USP <151> Pyrogen Test
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- A ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- > ASTM F88/F88M-21 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

- A USP <85> Bacterial Endotoxins Test
- A ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -A Part 20: Common test methods
- A ISO 8536-4:2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- A ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- > ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- > USP <788> Particulate Matter in Injections
- > ISTA 3A:2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less

In addition, the following verification or testing is performed to meet the stated performance requirements:

- > Extraction force testing in simulation using
- A Simulated Clinical Study for safety feature
- > Sharps injury protection testing in accordance with ISO 23908:2011 Sharps injury protection -Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

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Image /page/12/Picture/0 description: The image shows the word "CAINA" in large, blue, sans-serif font. The "A" in the word has a green triangle in the middle. Below the word "CAINA" is the text "www.cainainvest.com" in a smaller font.

# 10. Clinical Test Conclusion

Clinical studies are not required to demonstrate substantial equivalence to the predicate device.

- 11. Substantial Equivalence Conclusion
Based on the comparison and analysis above, the subject device, Safety Sliding Blood Collection Set is determined to be Substantially Equivalent (SE) to the predicate device, cleared under K980414 in intended use, principles of operation, technology, design, materials and performance.