(618 days)
FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
The provided text describes the 510(k) summary for the FEELject LDV (Low dead volume) Syringe, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new medical device meets specific acceptance criteria through a clinical study or AI performance evaluation.
Therefore, the information required to answer your specific questions about acceptance criteria, AI performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/device is not available in this document.
The document discusses bench testing and biocompatibility testing to show that the device performs in a substantially equivalent manner to the predicate device. These tests demonstrate the physical and biological properties of the syringe, not the performance of an AI algorithm or a diagnostic device.
Here's a breakdown of what can be extracted from the document, and why the other requested information is absent:
Information Available from the Document:
This document is a 510(k) summary for a medical device (syringe), not an AI algorithm. Therefore, the requested information about AI-related acceptance criteria, study design (MRMC, standalone), ground truth establishment for AI, and sample sizes for AI training/test sets is not applicable and not found in this text.
The closest equivalent to "acceptance criteria" here is compliance with ISO standards and passing various bench tests and biocompatibility tests to show substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance
While not "AI performance" criteria, the document lists various requirements/tests for the syringe and their results (Pass). These serve as the "acceptance criteria" for the syringe's physical and biological properties.
| Requirement - Test (ISO 7886-1) | Reported Device Performance (Result) |
|---|---|
| Limits for extractable metals | Pass |
| General | Pass |
| Limits for acidity or alkalinity | Pass |
| Conical fitting | Pass |
| Position of nozzle on end of barrel | Pass |
| Tolerance on graduated capacity | Pass |
| Scale | Pass |
| Numbering of scales | Pass |
| Overall length of scale to nominal capacity line | Pass |
| Position of scale | Pass |
| Barrel flanges | Pass |
| Plunger stopper/plunger assembly | Pass |
| Dead space | Pass |
| Freedom from air and liquid leakage past plunger stopper | Pass |
| Force to operate the piston | Pass |
| Fit of plunger stopper/plunger in barrel | Pass |
| Unit packaging and self-contained syringe units | Pass |
| Quantity of silicone oil | Pass |
| Requirement - Test (ISO 7864) | Reported Device Performance (Result) |
|---|---|
| Cleanliness | Pass |
| Tolerances on length | Pass |
| Needle Point, needles with sharp tip only | Pass |
| Bond between hub and needle tube | Pass |
| Patency lumen | Pass |
| Requirement – Test (ISO 9626) | Reported Device Performance (Result) |
|---|---|
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
| Requirement - Test (USP 788) | Reported Device Performance (Result) |
|---|---|
| Particulate matter injections | Pass |
| Biocompatibility Test Item | Test Method / Test Criteria | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | ISO 10993-5 Tests for in vitro cytotoxicity | Pass |
| Skin Sensitization Test | ISO 10993-10 irritation and skin sensitization | Pass |
| Intracutaneous Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization test for delayed hypersensitivity | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11 Test for systemic toxicity - Acute Systemic Toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Tests for systemic toxicity, Annex(F) Information on material-mediated pyrogens. | Pass |
| Hemolysis Test | ISO 10993-4 Selection of tests for interactions with blood | Pass |
| Sterility and LAL Test Item | Test Standard | Reported Device Performance (Result) |
|---|---|---|
| LAL test (Bacterial Endotoxins) | USP39 <85> (Unit : EU/Device) | Pass |
| Sterility test | According to ISO 11737-2 | Pass |
| E.O Residual | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals | Pass |
Information Not Applicable or Not Present:
The following information is specifically requested for AI/Software as a Medical Device (SaMD) performance studies, which are not described in this 510(k) summary for a physical medical device (syringe). Therefore, the answers are "Not Applicable" or "Not Provided" in this context.
- 2. Sample sized used for the test set and the data provenance: Not applicable. The tests are bench tests of physical characteristics, not data-driven AI test sets with specific sample sizes from a clinical population.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for a physical syringe.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI performance evaluation.
- 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: Not applicable. This is for AI performance evaluation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance evaluation. The device is a physical syringe.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This is for AI performance evaluation. The "ground truth" for the syringe is its compliance with specified physical and biological standards.
- 8. The sample size for the training set: Not applicable. There is no AI training set for a syringe.
- 9. How the ground truth for the training set was established: Not applicable. There is no AI training set for a syringe.
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May 31, 2023
Feeltech Co., Ltd. % Peter Chung President Plus Global 300. Atwood Pittsburgh, Pennsylvania 15213
Re: K213010
Trade/Device Name: FEELject LDV (Low dead volume) syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ, FMI Dated: April 28, 2023 Received: May 1, 2023
Dear Peter Chung:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Alan Guth
CAPT Alan M. Stevens 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
Enclosure
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Indications for Use
510(k) Number (if known) K213010
Device Name FEELject LDV(Low dead volume) Syringe
Indications for Use (Describe)
FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K213010 - 510(k) Summarv
[as required by 21 CFR 807.92(c)]
1. Applicant
- Company: Feeltech Co., Ltd. 1)
- Address: 3, 4 Floor, Standard Factory 2-dong, 15, Jayumuyeok2-gil, Gunsan-si, Jeollabuk-do, Korea 2)
- Tel : +82-63-468-6626~8 3)
- Fax : +82-63-468-6623 4)
- Prepared date : May 18, 2023 ર)
-
- Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
2. Subject Device Information
-
- Trade name: FEELject LDV(Low dead volume) Syringe
- Common name : Disposal syringe with needle 2)
-
- Classification name : Piston syringe
-
- Product code : QNQ, FMI
- Regulation number : 21 CFR 880.5860 ર)
- Class of device : Class II 6)
- Panel : General hospital 7)
3. The legally marketed device to which we are claiming equivalence
Syringe, K192551, Jiangsu Caina Medical Co., Ltd.
4. Device description
A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
5. Intended Use:
This product is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
6. Comparison Table
| Table 1. Comparison table of proposed to predicate device | ||||
|---|---|---|---|---|
| Manufacturer | FeelTech Co., Ltd. | Jiangsu Caina Medical Co., Ltd. | Remark | |
| Item | Proposed device | Predicate device | ||
| 510(K) No. | K213010 | K192551 | N/A | |
| Product | FEELject LDV Syringe | Syringe with permanentlyattached needle | ||
| Intended use | This product is intended for use to injectfluids into or withdraw from parts of thebody below the surface of the skin | This device is intended for use to injectfluids into or withdraw from parts of thebody below the surface of the skin | Same | |
| Components | Barrel, Plunger, Plunger rodNeedle, needle cap | Barrel, Plunger, Plunger rodNeedle, needle cap | Same | |
| Nozzle type | Permanently attached | Permanently attachedLuer-slip/Luer-lock | Different#1 | |
| Material | Barrel | Polypropylene (PP) | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | ||
| Piston | Rubber | Rubber | Same | |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | ||
| Needle | SUS304 | SUS304 | ||
| Needle cap | Polypropylene (PP) | Polypropylene (PP) | ||
| Capacity | 1ml | 0.3, 0.5, 1ml | Different#2 | |
| Dead space | Low dead volume (≤ 0.03 mL) | Unknown | Different#3 |
Table 1. Comparison table of proposed to predicate device
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| Principle ofoperation | Manual | Manual | Same |
|---|---|---|---|
| SyringePerformances¹ | Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part1 : Syringes for manual use | Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part1 : Syringes for manual use | Same |
| Needle Length | 25.0, 25.4, 38.1mm | 8, 10, 13 16, 20, 25mm | |
| Gauge | 23, 25G | 21, 23, 25, 26, 27, 28, 29, 30, 31G | Different |
| Needle Tipconfiguration | Bevel (11°±2°) | Bevel (11°±2°, 15°±2°) | #4 |
| Needle wall type | TW | RW, TW | |
| Needleperformance¹ | ISO 7864 : 2016 Sterile hypodermic needlesfor single use - Requirements and testmethodsISO 9626 : 2016 Stainless steel needletubing for the manufacture of medicaldevices - Requirements and test methods | ISO 7864 : 2016 Sterile hypodermic needlesfor single use - Requirements and testmethodsISO 9626 : 2016 Stainless steel needletubing for the manufacture of medicaldevices - Requirements and test methods | Same |
| Conforms to the | Conforms to the | ||
| Bio-Compatibility¹ | requirements of ISO 10993series standards.CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationHemolysisIntracutaneous reactivityBacterial Endotoxins | requirements of ISO 10993series standards.CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationHemolysisIntracutaneous reactivityBacterial Endotoxins | Same |
| Principle ofoperation | The plunger of syringe can be pulled andpushed along inside the barrel, allowing thesyringe to take in and expel the fluidsthrough the connector to the patient. | The plunger of syringe can be pulled andpushed along inside the barrel, allowing thesyringe to take in and expel the fluidsthrough the connector to the patient. | Same |
| Sterilizationmethod | E.O Gas sterilization | E.O Gas Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin limit¹ | 20 EU / Device | 20 EU / Device | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
- Note 1: Refer to the following section (8. Performance data) for the detail descriptions of conducted testing result.
7. Equivalence Discussion
1) Different #1 – Syringe nozzle type
Subject device only has permanently attached nozzle type. However, predicate device has not only permanently attached nozzle, but also luer-lock and luer-slip. While this configuration is different from each other, the subject device's nozzle configuration is included to the predicate device. Therefore, the differences on nozzle type does not raise new questions of safety and effectiveness.
- Different #2 Capacity 2)
Subject device has only one capacity configuration. (1 ml) Although predicate device has 3 configuration for the capacity (0.3, 0.5, 1 ml) this difference does not affect substantial equivalence because it is covered within the predicate submission.
3) Different #3 - Dead space
Subject device is intended to provide low dead volume (LDV), minimizing the loss of fluid left inside the syringe. Although predicate device does not have this aspect, subject device is better than its requirements for the dead space. In accordance with product code 'QNQ', this device has proved with related performance testing that it conforms to the FDA's requirements. Therefore, the differences between predicate and subject device does not affect the device's effectiveness and safety.
- Different #4 Needle configurations (Needle length, gauge, tip configuration, wall type) The needle configurations (Needle length, gauge, tip configuration, wall type) for proposed devices is different from the predicate devices. However, the predicate device covers the range of needle dimensions.
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Therefore, the differences on needle length and gauge does not affect safety and effectiveness.
8. Performance data evaluation
- Performance testing - Bench
Bench tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
| Requirement - Test (ISO 7886-1) | Result |
|---|---|
| Limits for extractable metals | Pass |
| General | Pass |
| Limits for acidity or alkalinity | Pass |
| Conical fitting | Pass |
| Position of nozzle on end of barrel | Pass |
| Tolerance on graduated capacity | Pass |
| Scale | Pass |
| Numbering of scales | Pass |
| Overall length of scale to nominal capacity line | Pass |
| Position of scale | Pass |
| Barrel flanges | Pass |
| Plunger stopper/plunger assembly | Pass |
| Dead space | Pass |
| Freedom from air and liquid leakage past plunger stopper | Pass |
| Force to operate the piston | Pass |
| Fit of plunger stopper/plunger in barrel | Pass |
| Unit packaging and self-contained syringe units | Pass |
| Quantity of silicone oil | Pass |
| Requirement - Test (ISO 7864) | Result |
|---|---|
| Cleanliness | Pass |
| Tolerances on length | Pass |
| Needle Point, needles with sharp tip only | Pass |
| Bond between hub and needle tube | Pass |
| Patency lumen | Pass |
| Requirement – Test (ISO 9626) | Result |
|---|---|
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
| Requirement - Test (USP 788) | Result |
|---|---|
| Particulate matter injections | Pass |
2) Biocompatibility
| # | Test item | Test method / Test criteria | Result |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 Tests for in vitro cytotoxicity | Pass |
| 2 | SkinSensitizationTest | ISO 10993-10 irritation and skin sensitization | Pass |
| 3 | IntracutaneousReactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization testfor delayed hypersensitivity | Pass |
| 4 | Acute SystemicToxicity Test | ISO 10993-11 Test for systemic toxicity - Acute Systemic Toxicity | Pass |
| 5 | Pyrogen Test | ISO 10993-11 Tests for systemic toxicity, Annex(F) Information onmaterial-mediated pyrogens. | Pass |
| 6 | Hemolysis Test | ISO 10993-4 Selection of tests for interactions with blood | Pass |
- Sterility and LAL test
| # | Test item | Test standard | Result |
|---|---|---|---|
| 1 | LAL test | USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| 2 | Sterility test | According to ISO 11737-2 | Pass |
| 3 | E.O Residual | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization | Pass |
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| test | residuals, the test articles should meet the test requirements. | |||
|---|---|---|---|---|
| -- | ------ | ----------------------------------------------------------------- | -- | -- |
Above conducted performance tests demonstrated that this device is performs in a substantially equivalent manner to the predicate device.
9. Conclusion
The device has completed testing to show that the device meets its intended use and demonstrates substantial equivalence to the predicate device, K192551. Therefore, it is concluded that the subject device, FEELject LDV (Low dead volume) Syringe is substantially equivalent to the legally marketed predicate device, K192551.
§ 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).