The Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Device Description

The proposed device, Savisafe Safety Device is a non-sterile, single use anti-needlestick accessory for pre-filled ISO standard glass syringe that are 1ml with a needle length of 1/2". The proposed device consists of four components:(1) Syringe sleeve, (2) Syringe holder, (3) Plunger rod. (4) Spring. The proposed device has a five-year shelf life.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Savisafe Safety Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria for many of the tests. Instead, it states that the device "complies with the requirements" or that "the proposed device is substantial equivalence with the predicate device." Where specific findings are reported, they are included.

Acceptance Criteria Category	Specific Test/Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-5:2009)	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.
	Irritation (ISO 10993-10:2010)	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.
	Sensitization (ISO 10993-10:2010)	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.
Safety Feature Performance	Safety Feature Activation Force Test (ISO 23908:2011)	The test results showed that the proposed device is substantially equivalent to the predicate device.
	Safety Feature Override Force Test (ISO 23908:2011)	The test results showed that the proposed device is substantially equivalent to the predicate device.
	Activation Reaction	Conducted to meet the design specification. (Specific result not detailed, but implied successful.)
	Access to the sharp in safe mode	Conducted to meet the design specification. (Specific result not detailed, but implied successful.)
Compatibility Performance	Tests with compatible pre-filled syringe	Demonstrated the compatibility between the proposed device and the pre-filled syringe. (Specific result not detailed, but implied successful.)
Durability/Transport	Simulated Transportation (ASTM D4169:2022)	Demonstrated the proposed device could function as intended after transportation. (Specific result not detailed, but implied successful.)
Simulated Clinical Study	Effect of safety feature (FDA Guidance Aug 9, 2005)	The test results demonstrated that the subject device complies with the requirements. (Specific result not detailed, but implied successful in preventing sharps injury under simulated conditions.)
Overall Conclusion	As safe, as effective, and performs as well as or better than predicate device.	The conclusion drawn from the non-clinical tests demonstrates that the proposed device, Savisafe Safety Device is as safe, as effective, and performs as well as or better than the legally marketed predicate device UltraSafe Passive PLUS Needle Guard (K123743). Additionally, the device is considered substantially equivalent to the predicate device based on the comparison of technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each individual non-clinical performance test. It mentions that tests were conducted "both on the proposed device and the predicate device" for the Safety Feature Performance tests.

The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) submission from a Chinese company, the testing was likely conducted in accordance with international standards, but the specific location of the test labs is not provided. All studies mentioned are non-clinical (laboratory/simulated), so "retrospective or prospective" doesn't strictly apply in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided in the document. The studies conducted are non-clinical performance tests (biocompatibility, mechanical performance, simulated clinical use), not studies involving expert interpretation of medical images or clinical outcomes. Therefore, there's no "ground truth" established by medical experts in the traditional sense for these types of device performance tests.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers or reviewers are making interpretations (e.g., of medical images) and their disagreements need to be resolved to establish a ground truth. The tests described are objective, non-clinical performance evaluations.

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:

This is not applicable as the device is a medical accessory (safety device for syringes), not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document, nor are human readers involved in the performance evaluation described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable since the device is a mechanical safety accessory, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, the "ground truth" is defined by adherence to established test standards and design specifications. For example:

Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as determined by the specified ISO standards.
Safety Feature Performance: The ability to activate and prevent override as per ISO 23908:2011 and deemed "substantially equivalent" to the predicate device.
Simulated Clinical Study: Compliance with the requirements of FDA Guidance "Medical Devices with Sharps Injury Prevention Features."

This isn't "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather objective measurement against predefined engineering and biocompatibility criteria.

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" as this device is a mechanical safety accessory and does not involve machine learning or AI that would require training data.

9. How the Ground Truth for the Training Set was Established:

This is not applicable since there is no training set.

Summary

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November 21, 2023

Suzhou Savicred Biotechnology Co., Ltd. % Ryan Li Consultant ICAS Group 155 Pingbei Rd, Minghang Shanghai. 201100 China

Re: K230287

Trade/Device Name: SaviSafe Safety Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: October 12, 2023 Received: October 16, 2023

Dear Ryan Li:

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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

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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) K230287

Device Name Savisafe Safety Device

Indications for Use (Describe)

The Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assust self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary K230287

I. Date Prepared [21 CFR 807.92(a)(1) ]

13th October, 2023

II. Submitter Information [21 CFR 807.92(a)(1)]

Suzhou Savicred Biotechnology Co., Ltd. 1F, 4th Building, No.818 Songjia Rd, Wuzhong District, Suzhou, Jiangsu, China Contact Person: Jiajun Zhu Title: Quality Manager Tel: 86-15250473569 Email: jiajun.zhu@savicred.com

Submission Correspondent: Ryan Li Email: 1ryryan0211@gmail.com Tel:+86 13701581791

III. Device Information [807.92(a)(2)]

Name of Device: Savisafe Safety Device Regulation Number: 21 CFR PART 880.5860 Common Name: Syringe, Antistick Classification Name: Piston syringe Regulatory Class: II Product Code: MEG

IV. Identification of Predicate Device [807.92(a)(3)]

Name of Device: UltraSafe Passive PLUS Needle Guard (K123743) Regulation Number: 21 CFR 880.5860 Common Name: Syringe, Antistick Classification Name: Piston syringe Regulatory Class: II Product Code: MEG

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510(K)

V. Device Description [807.92(a)(4)]

The proposed device, Savisafe Safety Device is a non-sterile, single use anti-needlestick accessory for pre-filled ISO standard glass syringe that are 1ml with a needle length of 1/2".

The proposed device consists of four components:(1) Syringe sleeve, (2) Syringe holder, (3) Plunger rod. (4) Spring. The proposed device has a five-year shelf life.

VI. Intended Use

VII. Indications for Use [21 CFR 807.92(a)(5)]

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VIII. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

The Savisafe Safety Device is compared with the predicate device, UltraSafe Passive PLUS Needle Guard (K123743). The results are shown below in the Technological Characteristics Comparison Table:

DEVICE	Savisafe Safety Device	UltraSafe Passive PLUS Needle Guard(K123743)	Remark
Indication for Use	The Savisafe Safety Device isindicated for use as an accessory withpre-filled ISO Standard glass syringesto aid in the protection of healthcareprofessionals, patients who self-injectdoctor prescribed medications andindividuals that assist self-injectingpatients, from accidental needlesticks.The intended patient population isunrestricted and may include childrenand adults, and parenteral methods ofadministration.	Single use devices that are indicated foruse as an accessory with pre-filled ISOStandard glass syringes to aid in theprotection of healthcare professionals,patients who self-inject doctor prescribedmedications and individuals that assistself-injecting patients, from accidentalneedlesticks. The intended patientpopulation is unrestricted and may includechildren and adults, and parenteralmethods of administration.Additionally, the PLUS device is designedwith a larger viewing window indicatedwhere phanna company offering is a lowfill volume and instructions requestvisualization. The PLUS device isdesigned with a robust plunger and built inextended finger flanges indicated wherepharma customer offering is viscous.	SimilarNote 1
ClassificationProduct Code	MEG	MEG	Same
Prescription Onlyor Over theCounter	Prescription	Prescription	Same
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Use	Single Use	Single Use	Same
Contraindication	None	None	Same
Configuration	Syringe sleeveSyringe holderPlunger rodSpring	GuardbodyPlungerSpring	SimilarNote 2
CompatibleSyringes	Pre-filled ISO Standard glass syringes	Pre-filled ISO Standard glass syringes	Same
Syringe Size	1ml	1ml	Same
Needle Length	1/2" length	1/2" length	Same
Safety FeatureMechanism	Passive Safety Feature	Passive Safety Feature	Same
Biocompatibility	Cytotoxicity:Under the conditions ofthe study, the subject device extractwas determined to be non-cytotoxic.Irritation:Under the conditions of thestudy, the subject device non-polar andpolar extracts were determined to benon-irritating.Sensitization:Under the conditions ofthe study, the subject device non-polarand polar extracts were determined tobe non- sensitizing.	Unknown	N/A
Sterilization	Non-sterile	Non-sterile	Same

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510(K)

Discussion in details:

Note 1: Both the proposed device and the predicate device are safety feature device used with pre-filled glass syringe to prevent sharps injury. The extra description of the predicate device's indications for use would not affect the substantial equivalence between the proposed device and the predicate device.

Note 2: Although the configuration of the proposed device is not the same as the predicate device, corresponding comparison performance tests are conducted on both the proposed device and the predicate device. The test result is shown the substantial equivalence. Therefore, the substantial equivalence between the proposed device and the predicate device is not affected by the configuration difference.

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Non-Clinical Performance Test Conclusion

Biocompatibility

The proposed device, Savisafe Safety Device is categorized as skin contact with a duration of category A-limited(≤24hrs) according to FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part1: Evaluation and testing within a risk management process". The

Biocompatibility tests were conducted to verify that the proposed devices are not adverse to human tissue based on the following standards:

ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for . in vitro cytotoxicity
. ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity

Safety Feature Performance

Performance tests regarding the safety feature are conducted both on the proposed device and the predicate device according to ISO 23908:2011 including:

Safety Feature Activation Force Test .
Safety Feature Override Force Test .

The test results shown that the proposed device is substantial equivalence with the predicate device.

Other performance tests are conducted to meet the design specification of the proposed device including:

. Free-fall Test
Activation Reaction ●
Access to the sharp in safe mode .

Compatibility Performance

Tests regarding proposed device with compatible pre-filled syringe are conducted to demonstrate the compatibility between the proposed device and the pre-filled syringe.

Simulated Transportation

A test is conducted according to ASTM D4169:2022 to demonstrate the proposed device could function as intended after transportation.

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510(K)

Simulated Clinical Study

In addition, a simulated clinical use study is conducted on the subject device, Savisafe Safety Device to evaluate the effect of safety feature per FDA Guidance " Medical Devices with Sharps Injury Prevention Features " issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.

Clinical Test Conclusion

No clinical study is included in this submission.

X. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrates that the proposed device, Savisafe Safety Device is as safe, as effective, and performs as well as or better than the legally marketed predicate device UltraSafe Passive PLUS Needle Guard(K123743).

Regulation Number and Section

§ 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).