(292 days)
No
The device description and performance studies focus on mechanical components and physical testing, with no mention of AI or ML.
No.
The device's intended use is to protect users from accidental needlesticks, and it is described as an "accessory with pre-filled ISO Standard glass syringes" and an "anti-needlestick accessory." It does not directly treat or diagnose a medical condition.
No
The device is described as an "anti-needlestick accessory" for syringes, designed to protect users from accidental needlesticks. Its intended use and description do not mention any diagnostic capabilities, such as detecting, identifying, or monitoring medical conditions.
No
The device description clearly states it consists of four physical components: Syringe sleeve, Syringe holder, Plunger rod, and Spring. It also details performance studies related to physical characteristics and safety features, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory for pre-filled syringes to prevent needlestick injuries. This is a physical safety function related to drug delivery, not a diagnostic test performed on biological samples.
- Device Description: The description details the physical components of a safety device for a syringe. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Mentioning any diagnostic parameters or metrics
The device's function is purely mechanical and related to the safe administration of medication via injection.
N/A
Intended Use / Indications for Use
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.
Product codes
MEG
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.
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
unrestricted and may include children and adults
Intended User / Care Setting
healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients
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 Performance Test Conclusion:
Biocompatibility: The proposed device, Savisafe Safety Device is categorized as skin contact with a duration of category A-limited(≤24hrs). Biocompatibility tests were conducted based on ISO 10993-1, ISO 10993-5:2009, and ISO 10993-10:2010.
Safety Feature Performance: Performance tests were conducted on both the proposed device and the predicate device according to ISO 23908:2011, including Safety Feature Activation Force Test and Safety Feature Override Force Test. Other tests included Free-fall Test, Activation Reaction, and Access to the sharp in safe mode. The test results showed substantial equivalence.
Compatibility Performance: Tests were conducted to demonstrate compatibility between the proposed device and compatible pre-filled syringes.
Simulated Transportation: A test was conducted according to ASTM D4169:2022 to demonstrate continued function after transportation.
Simulated Clinical Study: A simulated clinical use study was conducted on the subject device per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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
5
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
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.
VII. Indications for Use [21 CFR 807.92(a)(5)]
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.
6
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 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. | Single use devices that are 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.
Additionally, the PLUS device is designed
with a larger viewing window indicated
where phanna company offering is a low
fill volume and instructions request
visualization. The PLUS device is
designed with a robust plunger and built in
extended finger flanges indicated where
pharma customer offering is viscous. | Similar
Note 1 |
| Classification
Product Code | MEG | MEG | Same |
| Prescription Only
or Over the
Counter | 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 sleeve
Syringe holder
Plunger rod
Spring | Guard
body
Plunger
Spring | Similar
Note 2 |
| Compatible
Syringes | 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 Feature
Mechanism | Passive Safety Feature | Passive Safety Feature | Same |
| Biocompatibility | Cytotoxicity:Under the conditions of
the study, the subject device extract
was determined to be non-cytotoxic.
Irritation:Under the conditions of the
study, the subject device non-polar and
polar extracts were determined to be
non-irritating.
Sensitization:Under the conditions of
the study, the subject device non-polar
and polar extracts were determined to
be non- sensitizing. | Unknown | N/A |
| Sterilization | Non-sterile | Non-sterile | Same |
7
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.
8
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.
9
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).