(227 days)
SMB Hypodermic Syringe is used to inject fluid into or withdraw fluid from the body. This device is for single use only.
The SMB Luer lock disposable syringe is a standard Piston Syringe. It is a two-piece Syringe with male 6% luer lock connection. The Syringe is supplied with Hypodermic Needle having a female 6% luer hub. The Syringe and Needle are supplied sterilized by ETO gas. The device is single use device and non-pyrogenic. The device is available with 2ml Syringe and 23G Needle. A detailed description of Syringe and Needle is as follows: Syringe: The Syringe consists of hollow barrel with graduated scale and movable plunger. The barrel has a nozzle with a male luer lock connector that facilitates the connection with female luer lock hub of needle. The graduated scale on the barrel is indicated in the milliliters. The movable plunger is pulled to aspirate and pushed to inject the fluids into barrel. Needle: The Needle consists of Needle tube, Needle cap. The Needle tube is attached to the Needle hub and the Needle hub is attached to the syringe by luer lock system. A cap is provided to protect Needle sharps protection as well as prevention of injury.
The provided text is an FDA 510(k) clearance letter and associated documentation for a medical device: "SMB Luer lock disposable syringe." This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new AI/software-based device meets specific performance criteria through a study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth, training set), and effect sizes for an AI/software device cannot be extracted from this document, as it describes a physical medical device (syringe and needle) and its regulatory clearance based on comparison to existing, already cleared devices.
In summary, this document does not contain the information required to answer your prompt because it is not about an AI/software medical device or a study proving its performance against acceptance criteria.
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January 12, 2024
SMB Corporation of India % Atonu Datta, CEO Alceon Medtech Consulting 1008, 10th Floor, "OCEAN", Sarabhai Compound Near Centre Square mall, Dr. V.S. Marg Vadodara, Gujarat 390023, India
Re: K231558
Trade/Device Name: SMB Luer lock disposable syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: December 5, 2023 Received: December 11, 2023
Dear Atonu Datta:
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" (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).
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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 QS 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, Shruti N. Mistry -S
Shruti Mistry 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
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Indications for Use
510(k) Number (if known) K231558
Device Name SMB Luer lock disposable syringe
Indications for Use (Describe)
SMB Hypodermic Syringe is used to inject fluid into or withdraw fluid from the body. This device is for single use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential (Part 9, OBC, M-1 Division) | Care, Custodial (Part 3, OBC, M-2 Division) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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1. Submission Sponsor
Mr. Anupam Rai Chief QA Phone: +91260 2560209/+91 9930726998 Email id: qualityassurance@smbcorpn.com
SMB Corporation of India,
Plot No. 156 GIDC Umbergaon, Dist. Valsad 396170 Mfg. License No.: MFG/MD/2021/000092
2. Primary Correspondent
Mr. Atonu Dutta CEO Phone: (+91) 9925023428 Email: regulatory@alceonconsulting.com
Alceon Medtech Consulting
1008, 10th Floor, "OCEAN", Sarabhai Compound, Near Centre Square mall, Dr. V.S. Marg, Vadodara, Gujarat-390023, India. Phone: (+91) 9925023428
3. Date of preparing the summary
01/05/2024
4. Device Details
| Device name (Generic): | Hypodermic Syringe with Needle |
|---|---|
| Device name (Trade Name): | SMB Luer lock disposable syringe |
| Classification Regulation: | 21 CFR 880.5860, 21 CFR 880.5570 |
| Device Class: | Class II |
| Product Code: | FMF, FMI |
| Panel: | General hospital |
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5. Predicate Device
| Subject DeviceManufacturer | Subject Device | Primary PredicateDevice 510K | SecondaryPredicate Device510K |
|---|---|---|---|
| SMBCorporation ofIndia | Sterile, Single useHypodermic Syringe Withneedle | K202432 | K102584(For Needle) |
6. Device Description
The SMB Luer lock disposable syringe is a standard Piston Syringe. It is a two-piece Syringe with male 6% luer lock connection. The Syringe is supplied with Hypodermic Needle having a female 6% luer hub. The Syringe and Needle are supplied sterilized by ETO gas. The device is single use device and non-pyrogenic. The device is available with 2ml Syringe and 23G Needle.
A detailed description of Syringe and Needle is as follows:
Syringe: The Syringe consists of hollow barrel with graduated scale and movable plunger. The barrel has a nozzle with a male luer lock connector that facilitates the connection with female luer lock hub of needle. The graduated scale on the barrel is indicated in the milliliters. The movable plunger is pulled to aspirate and pushed to inject the fluids into barrel.
Needle: The Needle consists of Needle tube, Needle cap. The Needle tube is attached to the Needle hub and the Needle hub is attached to the syringe by luer lock system. A cap is provided to protect Needle sharps protection as well as prevention of injury.
The materials used in manufacturing of Syringe & Needle are safe as demonstrated by the biocompatibility study performed for biological evaluation. Table 1 gives information about raw material.
| Components | Material | Grade | CAS No. | Type ofBodyContact |
|---|---|---|---|---|
| Barrel | Polypropylene | RF830MO | 9010-79-1 | In directcontact withblood path |
| Plunger | HDPE | EHM 6007 | 9002-88-4 | In directcontact withblood path |
Table: 1 Raw Material
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| Components | Material | Grade | CAS No. | Type ofBodyContact |
|---|---|---|---|---|
| Needle tube | Stainless steel | SS304 | N/A | Directcontact withblood path |
| Needle hub | Polypropylene(Deep Blue colour) | RF830MO | 9010-79-1 | In directcontact withblood path |
| Needlecover | HDPE | EHM 6007 | 9002-88-4 | No contact |
Indication for use:
SMB Hypodermic Syringe is used to inject fluid into or withdraw fluid from the body. This device is for single use only.
7. Comparison to a predicate device
| Description | Subject Device(Applied) | Primary Predicate Device(K202432) | Comparison |
|---|---|---|---|
| Trade/DeviceName | SMB Luer lock disposablesyringe | MiniLoad Syringe | - |
| Manufacturer | SMB Corporation of India | OcuJect, LLC | - |
| 510 (K) | Applied | K202432 | - |
| Class | Class II | Class II | Same |
| Regulatorynumber | 21 CFR Part 880.5860 | 21 CFR Part 880.5860 | Same |
| Product code | FMF | FMF | Same |
| Syringe type | Piston Syringe | Piston Syringe | Same |
| Indication foruse | SMB Hypodermic Syringe isdevice that is used to injectfluid into or withdraw fluidfrom the body. This device isused for single use only. | The MiniLoad Syringe isused to facilitateinjections into orwithdraw fluids frombody. | Same |
| Configuration | Barrel | Barrel | Same |
| Plunger | Plunger | ||
| Materials | |||
| Description | Subject Device(Applied) | Primary Predicate Device(K202432) | Comparison |
| Barrel | Polypropylene | Polypropylene | Same |
| Plunger | Polyethylene | Polyethylene | Different 1 |
| Lubricant | Silicone oil | Oleamide | Different 1 |
| Principle ofoperation | Piston Syringe | Piston Syringe | Same |
| Technical specification | |||
| Barrel Length | $62 \pm 5mm$ | $\sim 85 mm$ | Different 2 |
| Barrel Diameter | $10.30 \pm 0.10mm$ | $\sim 6.4 mm$ | Different 3 |
| Barrel Size(Volume) | 2 ml | 1 ml | Different 4 |
| Plunger Length | $64 \pm 5mm$ | 93.4 | Different 5 |
| Nozzle type | Luer-lock | Slip Tip | Different 6 |
| Graduation | Printed, ISO 7886-1compliant | Printed, ISO 7886-1compliant | Same |
| Barreltransparency | Transparent (Fluid & scalemarking clearly visible) | Transparent | Same |
| Reuse durability | Single use only | Single use only | Same |
| SterilizationMethod | EO | EO | Same |
| SAL | $10^6$ | $10^6$ | Same |
| Biocompatibility | 1. Cytotoxicity2. Sensitization3. Irritation orIntracutaneousreactivity4. Acute systemictoxicity5. Material mediatedpyrogenicity6. Hemocompatibility | 1. Cytotoxicity2. Sensitization3. Irritation orIntracutaneousreactivity4. Acute systemictoxicity5. Material mediatedpyrogenicity6. Hemocompatibility | Same |
| ParticulateContamination | Met the USP<788> | Met the USP<788> | Same |
| Label/Labelling | Conform with 21 CFR 801 | Conform with 21 CFR 801 | Same |
| Shelf Life | 5 years | 5 Years | Same |
| Description | Subject Device(Applied) | Secondary PredicateDevice(K102584) | Comparison |
| Class | Class II | Class II | Same |
| Regulatory number | 21 CFR Part880.5570 | 21 CFR Part 880.5570 | Same |
| Product code | FMI | FMI | Same |
| Configuration | Needle HubNeedleNeedle Cover | Needle HubNeedleNeedle Cover | Same |
| Materials | |||
| Needle Hub | Polypropylene | Polypropylene | |
| Needle | S.S 304 | S.S 304 | Different 7 |
| Needle Cover | HDPE | Polypropylene | |
| Technical specification | |||
| Needle gauge | 23 G | 16 G to 30 G | Same- (Predicatedevice have someadditional gaugesizes) |
| Nozzle type | Luer-lock | Luer-lock/ Luer-Slip | Same- (Predicatedevice haveadditional nozzletype) |
| Needle cover color | Transparent | Transparent | Same |
| Hub/needle bondstrength | Complies as per ISO7864:2016 | Complies as per ISO7864:2016 | Same |
1. Comparison of Syringe to Predicate Device
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2. Comparison of Needle to Predicate Device
Summary of Substantial Equivalence:
Different 1, 7:
The subject and predicate devices contain a similar generic class of materials. However, the exact material grade of the predicate device is not publicly available. There may also be differences in manufacturing and processing aids that may result in a different finished material. Therefore, testing per ISO 10993 and the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing
SMB Corporation of India.
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within a risk management process" was performed to assess the biological impact of the finished material.
The results of biocompatibility studies were found satisfactory, and we conclude that the materials do not impact the safety and effectiveness of the subject device compared to the predicate device. Hence, the difference can be considered acceptable.
Different 2, 3, 4, 5:
The intended use of different sizes is the same as the predicate device. The raw material used for the subject device is similar to the predicate device. However, there may be differences in manufacturing and processing that results in a different finished material. Additionally, the device is tested in accordance with the ISO 7886-1:2017, ISO 80369-7:2016, ISO 7864:2016 standards and the results were found satisfactory. Considering these factors, the dimensional difference of barrel & needle does not impact the safety and effectiveness of the subject device when compared to the predicate device. Hence, the difference can be considered acceptable.
Different 6:
The predicate Hypodermic Needle is attached to the Hypodermic Syringe by means of lock or push fit (Slip) style. The subject device is attached by means of Luer-lock system. To address this difference, the subject device is tested in accordance with the ISO 7886-1:2017, ISO 80369-7:2016, ISO 7864:2016 standards and the results were found satisfactory. Considering the above difference, it is concluded that Luer-lock system will not result in liquid leakage and prevents accidental removal of needle. Hence, this difference can be considered acceptable.
For the needle cover, different materials were used for the subject device and predicate devices. Testing per ISO 10993 and the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a rick management process" was performed in order to assess the differences in finished material.
The results of biocompatibility were found satisfactory and the material difference does not impact the safety and effectiveness of the subject device when compared to the predicate device. Hence, the difference can be considered acceptable.
8. Summary of non-clinical performance data
Non-clinical tests were conducted to verify that the proposed devices met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
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| STANDARDS | TEST PARAMETERS |
|---|---|
| ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and testmethods |
| ISO 9626-2016 | Stainless steel needle tubing for the manufacture of medical devices- Requirements and test methods |
| ISO 594-1 | Conical fittings with a 6% (Luer) taper for syringes, needles andcertain other medical equipment - Part 1: General requirements |
| ISO 594-2 | Conical fittings with a 6% (Luer) taper for syringes, needles andcertain other medical equipment - Part 2: Lock fittings |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use - Part 1: Syringes for manualuse |
| USP 32 NF27 | Sterility |
| USP <85> | Bacterial Endotoxin test |
| USP <788> | Particulate contamination |
| Biocompatibility | |
| ISO 10993-11:2021 | Acute Systemic toxicity |
| ISO 10993-5:2009 | Cytotoxicity |
| ISO 10993-10: 2021 | Skin sensitization study in guinea pigs |
| ISO 10993-10: 2021 | Intracutaneous reactivity test |
| USP-39NF-34,Chapter 151 & ISO10993-11 | Material mediated Pyrogenicity |
| ISO 10993-4 | Hemocompatibility Test |
| ISO 10993-4:2017 | Extract Method |
| ASTM F 756-17 | Direct Contact Method |
| Packaging Test: | |
| ISO 11607-1:20192nd edition | Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems, and packagingsystems |
| ISO 11607-2:20192nd edition | Packaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing, and assemblyprocesses |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containersand Systems |
| Sterilization Test: | |
| STANDARDS | TEST PARAMETERS |
| ISO11135:2014/AMD1:2018 2nd edition | Sterilization of health care products - Ethylene oxide - Requirementsfor development, validation, and routine control of a sterilizationprocess for medical devices. |
| EO Residual Test: | |
| ISO 10993-7:2008 | Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals, and it meets the requirements of thestandard. |
| Bacterial Endotoxin Test: | |
| USP <85> | The Bacterial endotoxin testing of subject devices was performed bythe "Gel-Clot Method" and meets the requirement of USP <85>. |
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9. Summary of clinical performance data
No clinical data is included in this premarket application submission.
10. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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).