(85 days)
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
SEZ Safety Syringe consists of 1) a calibrated hollow barrel which contains medication and, after use, confines 2) the needle, 3) a movable plunger which aspirates medication and, after injection, retracts the needle into the barrel, At the distal end of the barrel, there is a female connector(nozzle) for fitting 3) a male connector(hub) to which the needle is firmly attached by bonding material. The needle is securely protected by 5) a cap before use. For sealing purpose, 6) an o-ring, between barrel and hub, and a gasket, between barrel and plunger, are used. The function of the device is to deliver medication and, after injection, to destroy the needle in the barrel to prevent needlestick injury and possible reuse. The injection process is practically the same as that of the conventional, non-safety, syringes, that is, to aspirate medication from a vial and to deliver it to a patient. The disposal process is turn-pull-push operation, each step of which is clearly and unmistakably defined. By turning the knob of the plunger half round clockwise, hub is disassembled from the barrel. Then plunger is pulled backward until it stops, which retracts hub and needle into the barrel. Needle is tilted to one-side pushed by the rod at plunger head. Finally, the plunger is pushed forward to crumble the needle in the barrel. Needle and contaminated fluid are contained in the barrel safely and used syringe can be discarded in the sharps container.
The provided text describes the SEZ Safety Syringe, a device for intramuscular and subcutaneous injection that aims to prevent needlestick injuries. A 510(k) submission (K031163) was made to the FDA, asserting its substantial equivalence to the EXEL Secure Touch Safety Syringe (K011754).
Here's an analysis of the acceptance criteria and the study as described in the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, emphasizing safety and effectiveness, especially in preventing needlestick injuries, and adherence to relevant standards. The "reported device performance" is primarily a statement of equivalence and clinical acceptability.
| Acceptance Criteria Category | Specific Criteria (Implicitly from Comparison Document) | SEZ Safety Syringe Performance (Reported in 510(k) Summary) |
|---|---|---|
| Intended Use | Safety hypodermic syringe for intramuscular and subcutaneous medication injection, aiding in needlestick injury prevention. | Identical to predicate device. |
| Principle of Operation | Safety feature activation: 1. Disassemble needle assembly by turning plunger. 2. Retract needle into barrel and confine it. Break plunger before disposal. | Identical, except needle confinement is guaranteed by pushing the plunger forward before disposal (instead of breaking the plunger). This is presented as an equivalent mechanism. |
| Volume (ml/cc) | Available in 3 and 5 ml/cc. | Available in 3 ml/cc. (The 5ml/cc variant is not mentioned for SEZ, but 3ml/cc is present, implying a subset comparison for available sizes). |
| Nozzle Type | Male conical lock fitting with rotatable internally threaded collar. | Female conical lock fitting with rotatable internally threaded neck. (Presented as a design difference but not a functional deviation from safety/effectiveness). |
| Barrel Marking | Conforms to ISO 7886-1:1993(E) standard. | Identical to predicate device. |
| Reuse | Non-reusable. | Identical to predicate device. |
| Biocompatibility | Conforms to ISO 10993-1. | Identical to predicate device. |
| Materials | Specific plastic parts, gasket, o-ring, packing film, packing paper as listed for predicate. | Identical to predicate device materials. |
| Sterility | Sterilized by ethylene oxide gas, SAL = 10^-6. | Identical to predicate device. |
| Overall Safety & Effectiveness | Substantially equivalent to predicate device, including needlestick injury prevention. | "In all material respects, the SEZ Safety Syringe is substantially equivalent to the predicate device." "The results of the investigation showed that the SEZ Safety Syringe is clinically acceptable." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A clinical investigation was performed in conformity with the requirements specified in Annex X of MDD93/42/EEC, and test for the comparison between SEZ Safety Syringe and the legally marketed predicate device was performed in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'."
- Sample Size: The exact sample size for the "clinical investigation" or "test for the comparison" is not specified in the provided text.
- Data Provenance: The MDD93/42/EEC (Medical Devices Directive) indicates European regulatory compliance, suggesting the clinical investigation likely took place in a country adhering to these regulations. The "Guidance for Industry and FDA" suggests the data was also considered for the US FDA submission. The text does not explicitly state if the study was retrospective or prospective, but clinical investigations typically imply a prospective approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. Clinical investigations for device comparison often involve assessments by nurses or other healthcare professionals, but their specific roles in establishing a "ground truth" (e.g., for injury events) or their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
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
- MRMC Study: This is not applicable as the device is a mechanical safety syringe, not an AI-powered diagnostic or assistive technology for "human readers."
- Effect Size of AI assistance: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a mechanical safety syringe, not an algorithm. Performance is assessed on its mechanical function and safety features in preventing injuries.
7. The Type of Ground Truth Used
For a mechanical safety device like a syringe, the "ground truth" typically involves:
- Performance Metrics: Successful activation of the safety mechanism, prevention of needlestick injuries, proper medication delivery, and ease of use.
- User Feedback/Observations: Direct observation of users (healthcare professionals) using the device, recording successful safety feature activation, and instances of failure or injury.
- Biocompatibility Testing: Lab-based testing to ensure no adverse biological reactions (conforms to ISO 10993-1).
- Physical Testing: Mechanical tests to confirm strength, durability, and compliance with standards (e.g., barrel marking to ISO 7886-1).
The provided text states: "The results of the investigation showed that the SEZ Safety Syringe is clinically acceptable." This implies the ground truth was established through direct observation and measurement of the device's performance in a clinical setting against established safety and functional criteria for syringes with sharps injury prevention features.
8. The Sample Size for the Training Set
This is not applicable as the device is a mechanical safety syringe and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device does not require a "training set."
{0}------------------------------------------------
EXHIBIT 2 SEZ Corporation
#401, Simon Bldg. 943-15. Daechi-dong, Gangnam-Gu, Seoul, Korea Tel: 82-2-5566-090 Fax: 82-2-5566-091 May 19, 2003 Contact: G.S. Pok, Managing Director 510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: SEZ Safety Syringe Classification Name: Piston Syringe Common/Usual Name: Safety Syringe
-
- Equivalent legally marketed device: EXEL Secure Touch Safety Syringe, K011754
-
- Indications for Use (intended use) . This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
-
- Description of the Device: SEZ Safety Syringe consists of 1) a calibrated hollow barrel which contains medication and, after use, confines 2) the needle, 3) a movable plunger which aspirates medication and, after injection, retracts the needle into the barrel, At the distal end of the barrel, there is a female connector(nozzle) for fitting 3) a male connector(hub) to which the needle is firmly attached by bonding material. The needle is securely protected by 5) a cap before use. For sealing purpose, 6) an o-ring, between barrel and hub, and a gasket, between barrel and plunger, are used. The function of the device is to deliver medication and, after injection, to destroy the needle in the barrel to prevent needlestick injury and possible reuse. The injection process is practically the same as that of the conventional, non-safety, syringes, that is, to aspirate medication from a vial and to deliver it to a patient. The disposal process is turnpull-push operation, each step of which is clearly and unmistakably defined. By turning the knob of the plunger half round clockwise, hub is disassembled from the barrel. Then plunger is pulled backward until it stops, which retracts hub and needle into the barrel. Needle is tilted to one-side pushed by the rod at plunger head. Finally, the plunger is pushed forward to crumble the needle in the barrel. Needle and contaminated fluid are contained in the barrel safely and used syringe can be discarded in the sharps container..
JUL 0 8 2003
{1}------------------------------------------------
| Device name | Predicate syringeEXEL Secure Touch Safety Syringe (K011754) | SEZ safety syringe |
|---|---|---|
| Intended Use | This device is a safety hypodermic syringefor injection of medication to patients.This device aids in prevention of needlestickinjuries. | Identical |
| Principle of operation | Activation of safety feature consists oftwo steps:1) Disassemble needle assemblyfrom the barrel by turningthe plunger. | Identical |
| 2) Retract needle into barrel andconfine it in the barrel bypulling the plunger backward.To guarantee confinement ofneedle, break the plungerbefore disposal. | Identical,except that needleconfinement isguaranteed by pushingthe plunger forwardbefore disposal. | |
| Volume (ml/cc) | 3 and 5 combined | 3 |
| Nozzle type | Male conical lock fitting withrotatable internally threadedcollar | Female conical lockfitting with rotatableinternally threadedneck |
| Barrel marking | - Scale : conforms toISO 7886-1:1993(E) | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conforms to ISO 10993-1 | Identical |
| Materials | 1) Plastic parts : polypropylene (homo type)2) Gasket : thermoplastic rubber3) O-ring : nitrile rubber4) Packing film : Medipeel film5) Packing paper : Ethypel paper | IdenticalIdenticalIdenticalIdenticalIdentical |
| Sterility | Sterilized by ethylene oxide gas$SAL=10^{-6}$ | Identical |
-
- Safety and Effectiveness, comparison to predicate device:
Conclusion: In all material respects, the SEZ Safety Syringed is substantially 6. equivalent to the predicate device. The conclusion is based on biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the predicate device. A clinical investigation was performed in conformity with the requirements specified in Annex X of MDD93/42/EEC, and test for the comparison between SEZ Safety Syringe and the legally marketed predicate device was performed in accordance with "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA". The results of the investigation showed that the SEZ Safety Syringe is clinically acceptable.
- Safety and Effectiveness, comparison to predicate device:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 8 2003
Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015
Re: K031163
Trade/Device Name: SEZ Safety Intramuscular/Subcutaneous Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 2, 2003 Received: April 15, 2003
Dear Mr. Kamm:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{3}------------------------------------------------
Page 2 - Mr. Kamm
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan B. Anno
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
j) Indications for Use 火03 11163 510(k) Number_
Device Name: SEZ Safety Syringe
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use __ X (Per 21 CFR 801.109)
Patturn Cuccerite
(Division Sign-C Division of Anesthesiology, General Hospital tion Control, Dent
510(k) Number: K031163
,
§ 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).