(119 days)
The ACE Cannula is intended to inject fluids intradermally.
The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient.
The provided document is a 510(k) summary for a medical device called the "ACE Cannula." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a clinical study or performance data based on human-in-the-loop or standalone AI performance.
Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment (for training and test sets) is not applicable to this type of submission. This document outlines bench testing for physical characteristics, material safety (biocompatibility), and sterility, all of which are laboratory-based and do not involve patient data or expert reader studies in the way you've described for AI/CADe devices.
Here's an analysis based on the information that is present in the document:
Device: ACE Cannula
Purpose: Intended to inject fluids intradermally.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACE Cannula are based on compliance with international standards for medical devices, specifically hypodermic needles and cannulas, and biocompatibility. The "reported device performance" is the manufacturer's assertion that the device "Pass"ed all these tests.
| Requirements - Test (Standard) | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (ISO 7864) | ||
| Appearance | Meet visual specifications | Pass |
| Color coding (Section 4.7) | Correct color coding | Pass |
| Color of hub (Section 4.8.2) | Correct color of hub | Pass |
| Needle tube Tolerance on length (Section 4.10.2) | Within specified tolerance | Pass |
| Needle tube Freedom from defects (Section 4.10.3) | Free from defects | Pass |
| Needle point (Section 4.11) | Meet point specifications | Pass |
| Bond between hub and needle tube (Section 4.12) | Secure bond | Pass |
| Patency of lumen (Section 4.13) | Lumen unobstructed | Pass |
| Mechanical Performance (ISO 9626) | ||
| Dimension (Section 5.6) | Within specified dimensions | Pass |
| Stiffness (Section 5.8) | Meet stiffness requirements | Pass |
| Resistance to breakage (Section 5.9) | Does not break under specified conditions | Pass |
| Resistance to corrosion (Section 5.10) | Resists corrosion | Pass |
| Luer Connector Performance (ISO 80369-7, ISO 80369-20) | ||
| Leakage by pressure decay (6.1.2/Annex B) | No leakage beyond acceptable limits | Pass |
| Positive Pressure Liquid Leakage (6.1.3/Annex C) | No leakage under positive liquid pressure | Pass |
| Sub-atmospheric Pressure Air Leakage (6.2/Annex D) | No air leakage under sub-atmospheric pressure | Pass |
| Stress Cracking (6.3/Annex E) | No cracking under stress | Pass |
| Resistance to separation from axial load (6.4/Annex F) | Resists separation under axial load | Pass |
| Resistance to separation from unscrewing (6.5/Annex G) | Resists separation when unscrewed | Pass |
| Resistance to overriding (6.6/Annex H) | Luer connection does not override | Pass |
| Disconnection by unscrewing (Annex I) | Allows disconnection by unscrewing | Pass |
| Chemical Properties (ISO 7864) | ||
| Extraction: pH | Difference of pH shall be ≤ 1.0 | Pass |
| Extraction: Potassium permanganate reducing substances | Difference of the consumption shall be ≤ 2.0 mL | Pass |
| Extraction: Residue on evaporation | Amount of residue shall be ≤ 1.0 mg | Pass |
| Extraction: Pb, Fe, Sn, Zn (Heavy metals) | Total content of heavy metals shall be ≤ 5.0 mg/L | Pass |
| Extraction: Cd | Content of Cd shall be ≤ 0.1 mg/L | Pass |
| Biocompatibility (ISO 10993-1, -4, -5, -7, -10, -11) | ||
| Cytotoxicity test | Should satisfy requirements (e.g., no toxic leachate) | Pass |
| Hemolysis test | Should satisfy requirements (e.g., no significant hemolysis) | Pass |
| Intracutaneous reactivity test | Should satisfy requirements (e.g., no significant irritation) | Pass |
| Skin sensitization test | Should satisfy requirements (e.g., no sensitization) | Pass |
| Acute systemic toxicity test | Should satisfy requirements (e.g., no systemic toxic effects) | Pass |
| Pyrogen Test | Should satisfy requirements (e.g., no pyrogenic response) | Pass |
| Particulate Matter Injection (USP <788>) | Meet USP <788> requirements for particulate matter | Pass |
| Sterility & EO Residuals (ISO 11135, ISO 11737-2, ISO 10993-7) | ||
| LAL test (Bacterial Endotoxins) | Meet USP39 <85> requirements (Unit : EU/Device) | Pass |
| E.O sterilization validation | Meet ISO 11135:2014 requirements for sterilization | Pass |
| Sterility test | Meet ISO 11737-2 requirements (e.g., sterile to SAL 10^-6^) | Pass |
| E.O Residual test | Meet ISO 10993-7:2008 requirements for EO residuals | Pass |
2. Sample size used for the test set and the data provenance:
- This is a 510(k) submission for a conventional medical device (a cannula), not an AI/CADe device. The "test set" here refers to samples of the device undergoing laboratory bench testing according to various ISO standards.
- The document does not specify the exact sample size for each individual bench test (e.g., how many cannulas were tested for bond strength). However, it implies that sufficient samples were tested to demonstrate compliance with the relevant standards.
- Data Provenance: The tests were conducted by Ace Medical Industry Co., Ltd. (Korea, as per company address in the 510(k) summary) or a qualified third-party lab under their direction. These are prospective tests performed on newly manufactured devices to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device's performance is evaluated through physical, chemical, and biological laboratory tests against pre-defined, objective engineering and safety standards (e.g., ASTM, ISO standards). It does not involve subjective human interpretation of data (like medical images), so no human experts are needed to establish "ground truth" for a test set in the clinical sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, the testing is objective and based on engineering/scientific measurements, not subjective human assessments requiring adjudication.
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 relates to AI/CADe devices assisting human clinicians. The ACE Cannula is a physical, sterile, single-use device for fluid injection, not an AI or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to the performance of an AI algorithm. The ACE Cannula does not have an "algorithm" in this context. Its "performance" is its mechanical, material, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the tests performed, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, USP, ASTM). For example, "pass" for patency of lumen means the lumen was unobstructed as per the standard's definition; "pass" for cytotoxicity means the extracts did not cause a cytotoxic effect beyond the acceptable limits defined in ISO 10993-5. It is based on objective, measurable criteria rather than expert consensus or clinical outcomes data relevant to AI/CADx devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of device. The device is manufactured and then tested for compliance with established standards. There is no machine learning model being trained.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The product's design and manufacturing rely on engineering principles, material science, and established quality control practices.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The Department of Health and Human Services seal is a circular emblem with a stylized caduceus in the center. The FDA acronym is in a blue square, and the words "U.S. Food & Drug Administration" are in blue text to the right of the square.
January 8, 2025
Ace Medical Industry Co., Ltd. c/o Peter Chung CEO Plus Global 300. Atwood Street Pittsburgh, PA 15213 Re: K242741 Trade/Device Name: ACE Cannula Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 8, 2024 Received: November 12, 2024
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 (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"
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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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 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) K242741
Device Name ACE Cannula
Indications for Use (Describe) The ACE Cannula is intended to inject fluids intradermally.
| 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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Image /page/4/Picture/0 description: The image shows the logo for ACE, a company that focuses on safety. The logo features the word "ace" in a stylized, italicized font, with a blue color scheme. Below the word "ace" is the tagline "For your safety" in a smaller font. The logo is simple and professional, conveying a sense of trust and reliability.
K242741 510(k) Summarv
1. Applicant information
- Company: Ace Medical Industry Co., Ltd. 1)
- Address: 57-14, Gwangjeok-ro 228beon-gil, Yangju-si, Gyeonggi-do, Korea 2)
- Tel: 82-31-944-1182 3)
-
- Prepared date: January 8, 2025
- ર) Contact person: Peter Chung
- Contact person address: 300, Atwood Street, Pittsburgh, PA, 15213, USA 6)
-
- Contact person Tel: 412-512-8802
- Submission date: November 8, 2024 8)
2. Device Information
-
- Trade name: ACE Cannula
- Common name: Hypodermic single lumen needle 2)
-
- Regulation name: Needle, Hypodermic, Single Lumen
- Product code: FMI 4)
- Regulation number: 880.5570 ર)
- Class of device: Class II 6)
-
- Panel: General Hospital
3. The legally marketed device to which we are claiming equivalence
K200017, Eclipse Medcorp LLC. / Eclipse DermaFlex Cannula
4. Device description
The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub.
The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient. The thirteen models are as follows: AN-2125, AN-2613, AN-2625, AN-2725, B-2260, B-2270, B-2540, B-2550, B-2725, B-2738, B-2750, and B-3025.
| Model | Gauge | Length of needle(mm) | Out diameter of needle(mm) |
|---|---|---|---|
| AN-2125 | 21 | 25 | 0.800~0.830 |
| AN-2325 | 23 | 25 | 0.600~0.673 |
| AN-2613 | 26 | 13 | 0.440~0.470 |
| AN-2625 | 26 | 25 | 0.440~0.470 |
| AN-2725 | 27 | 25 | 0.400~0.420 |
| B-2260 | 22 | 60 | 0.698~0.730 |
| B-2270 | 22 | 70 | 0.698~0.730 |
| B-2540 | 25 | 40 | 0.500~0.530 |
| B-2550 | 25 | 50 | 0.500~0.530 |
| B-2725 | 27 | 25 | 0.400~0.420 |
| B-2738 | 27 | 38 | 0.400~0.420 |
| B-2750 | 27 | 50 | 0.400~0.420 |
| B-3025 | 30 | 25 | 0.298~0.320 |
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Image /page/5/Picture/0 description: The image shows the logo for ACE, a company that focuses on safety. The logo is in blue and features the word "ACE" in a stylized font, with a slanted line above the letters. Below the logo, the tagline "For your safety" is written in a smaller, italicized font.
5. Indications For Use
The ACE Cannula is intended to inject fluids intradermally.
6. Performance data:
-
- Bench tests for the device's performance were conducted. Bench testing includes 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.
| Requirements - Test (ISO 7864) | Result |
|---|---|
| Appearance | Pass |
| Color coding (Section 4.7) | Pass |
| Color of hub (Section 4.8.2) | Pass |
| Needle tube Tolerance on length (Section 4.10.2) | Pass |
| Needle tube Freedom from defects (Section 4.10.3) | Pass |
| Needle point (Section 4.11) | Pass |
| Bond between hub and needle tube (Section 4.12) | Pass |
| Patency of lumen (Section 4.13) | Pass |
| Requirements - Test (ISO 9626) | Result |
|---|---|
| Dimension (Section 5.6.) | Pass |
| Stiffness (Section 5.8.) | Pass |
| Resistance to breakage (Section 5.9.) | Pass |
| Resistance to corrosion (Section 5.10) | Pass |
| Requirements - Test (ISO 80369-7, ISO 80369-20) | Result |
|---|---|
| Leakage by pressure decay (ISO 80369-7: 6.1.2, ISO 80369-20: Annex B) | Pass |
| Positive Pressure Liquid Leakage (ISO 80369-7: 6.1.3, ISO 80369-20: Annex C) | Pass |
| Sub-atmospheric Pressure Air Leakage (ISO 80369-7: 6.2, ISO 80369-20: Annex D) | Pass |
| Stress Cracking (ISO 80369-7: 6.3, ISO 80369-20: Annex E) | Pass |
| Resistance to separation from axial load (ISO 80369-7: 6.4, ISO 80369-20: Annex F) | Pass |
| Resistance to separation from unscrewing (ISO 80369-7: 6.5. ISO 80369-20: Annex G) | Pass |
| Resistance to overriding (ISO 80369-7: 6.6, ISO 80369-20: Annex H) | Pass |
| Disconnection by unscrewing (ISO 80369-20, Annex I) | Pass |
| Test item | Requirements | Result | |
|---|---|---|---|
| Extraction: pH | Difference of pH shall be ≤ 1.0 | Pass | |
| Extraction: Potassiumpermanganate reducingsubstances | Difference of the consumption shall be ≤ 2.0 mL | Pass | |
| Extraction: Residue onevaporation | Amount of residue shall be ≤ 1.0 mg | Pass | |
| Extraction: Pb, Fe, Sn, Zn | Total content of heavy metals shall be ≤ 5.0 mg/L | ||
| Extraction: Cd | Content of Cd shall be ≤ 0.1 mg/L | Pass |
2) Biocompatibilitv
Biocompatibility of the ACE Cannula / Q Micro Cannula was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device -Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were
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Image /page/6/Picture/0 description: The image shows the logo for ACE, which is a company that focuses on safety. The logo is in blue and features the word "ACE" in a stylized font. Below the logo is the tagline "For your safety" in a smaller font. The logo is simple and professional, and it conveys the company's commitment to safety.
performed, as recommended: Cytotoxicity; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity; Pyrogenicity. All evaluation acceptance criteria were met.
| Test item | Test method / Test criteria | Test result |
|---|---|---|
| Cytotoxicitytest | When it was tested accordingly to ISO 10993-5, tests for in vitrocytotoxicity-Test on extracts method, it should satisfy the requirements. | Pass |
| Hemolysistest | When it was tested accordingly to ISO 10993-4, Selection off tests forinteractions with blood-evaluation of hemolytic properties of medicaldevices and medical device materials, it should satisfy the requirements. | Pass |
| Intracutaneous reactivitytest | When it was tested accordingly to ISO 10993-10, Tests for irritation andskin sensitization-Animal intracutaneous (Intradermal) reactivity test, itshould satisfy the requirements. | Pass |
| Skinsensitizationtest | when it was tested accordingly to ISO 10993-10, Tests for irritation andskin sensitization-Guinea pig maximization test (GPMT), it should satisfythe requirements. | Pass |
| Acutesystemictoxicity test | When it was tested accordingly to ISO 10993-11, Tests for systemictoxicity-Acute systemic toxicity, it should satisfy the requirements. | Pass |
| PyrogenTest | When it was tested accordingly to ISO 10993-11, Tests for systemictoxicity-Information on material-mediated pyrogens, it should satisfy therequirements. | Pass |
| ParticulateMatterInjection | USP <788>, Particulate Matter for Injections (Method 1 LightObscuration Particle Count Test). Test result should satisfy therequirements described in the USP <788> | Pass |
3) Sterility and LAL test
The sterilization method has been validated to ISO 11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards:
| Test item | Test standard | Test result |
|---|---|---|
| LAL test | USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| E.O sterilization validation | According to ISO 11135:2014E.O 30%, CO2 70%Temperature: 50 $\pm$ 7°CExposure time: 5 hours | Pass |
| Sterility test | According to ISO 11737-2 | Pass |
| E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals, the test articles should meet the test requirements. | Pass |
7. Predicate device comparison table
| Manufacturer | ACE Medical Industry Co., Ltd. | Eclipse Medcorp. LLC. | Remark |
|---|---|---|---|
| 510(K) No. | K242741 | K200017 | N/A |
| Device name | ACE Cannula (13 models including AN-2260) | Eclipse DermaFlex Cannula | N/A |
| Indications for use | The ACE Cannula, Duo Cannula, Q MicroCannula is intended to inject fluidsintradermally. | The Eclipse DermaFlex Cannula is intended toinject fluids intradermally. | Identical |
| Principle ofOperation | This device is used in conjunction with a pistonsyringe to deliver fluids/medications/drugs intothe body. The device consists of a metaltube(needle), joined to a femaleconnector(hub). This device comes in a varietyof needle gauges and lengths. | This device is used in conjunction with a pistonsyringe to deliver fluids/medications/drugs intothe body. The device consists of a metaltube(needle), joined to a femaleconnector(hub). This device comes in a varietyof needle gauges and lengths. | Identical |
| Structure | Hub, Needle, Protective Cap | Hub, Needle, Protective Cap | Identical |
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Image /page/7/Picture/0 description: The image shows the logo for ACE, which is a company that focuses on safety. The logo is blue and features the word "ACE" in a stylized font. Below the word "ACE" is the tagline "For your safety" in a smaller font. The logo is simple and professional, and it conveys the company's focus on safety.
| Needle Length | 13, 25, 38, 40, 50, 60, 70mm | 25, 38, 40, 50, 60, 70mm | Different#1 |
|---|---|---|---|
| Needle Gauge | 21G, 22G, 23G, 25G, 26G, 27G, 30G | 21G, 22G, 23G, 25G, 26G, 27G, 30G | Identical |
| Tip configuration | Sharpened tip (pilot needle)Closed blunt tip with lateral opening(intradermic needle) | Sharpened tip (pilot needle)Closed blunt tip with lateral opening(intradermic needle) | Identical |
| Hub structure | Luer Taper | Luer Taper | Identical |
| Material | |||
| Hub of needle | Polypropylene (PP) | Polypropylene (PP) | Identical |
| Protective Cap | Polypropylene (PP) | Polypropylene (PP) | Identical |
| Cannula | Stainless Steel 304 | Stainless Steel 304 | Identical |
| Adhesive | Epoxy Resin | Epoxy Resin | Identical |
| Lubricant | Silicone | Silicone | Identical |
| Comforms to the following standards:ISO 7864 : 2016 Sterile hypodermic needles forsingle use - Requirements and test methods | Complies to the following standards:ISO 7864 : 2016 Sterile hypodermic needles forsingle use - Requirements and test methods | Identical | |
| NeedlePerformanceRequirements | ISO 9626 : 2016 Stainless steel needle tubingfor the manufacture of medical devices -Requirements and test methods | ISO 9626 : 2016 Stainless steel needle tubingfor the manufacture of medical devices -Requirements and test methods | Identical |
| Biocompatibility | Conforms to the requirements of ISO 10993series standards. | Conforms to the requirements of ISO 10993series standards. | Identical |
| Cytotoxicity | Cytotoxicity | Identical | |
| Hemolysis test | Hemolysis test | Identical | |
| Pyrogen test | Pyrogen test | Identical | |
| Intracutaneous reactivity test | Intracutaneous reactivity test | Identical | |
| Skin sensitization test | Skin sensitization test | Identical | |
| Acute systemic toxicity test | Acute systemic toxicity test | Identical | |
| LAL test (Endotoxin) | LAL test (Endotoxin) | Identical | |
| Sterility test | Sterility test | Identical | |
| E.O. Gas Residual | E.O. Gas Residual | Identical | |
| Sterilization | E.O sterilization | E.O sterilization | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Identical |
Equivalence Discussion
Different #1: Length of needle
The subject device has a very similar range of needle length. However, it additionally has a 13 mm length configuration, and this needle length is not included in the legally marketed device (K200017). However, this needle configuration is widely used in the clinical field. Also, the different needle configurations present do not affect the indications for the equipment itself. To validate this claim, performance testing for the needle component was conducted. In accordance with internationally recognized standards (ISO 7864, ISO 9626), it has been proved that the needle configuration of the proposed device conforms with the relevant standard. Therefore, the differences in configuration do not raise any new questions about its safety and/or effectiveness.
8. Sterility, Shipping and Shelf-Life
Sterilization validation was performed in accordance with ISO 11135:2014 to prove that the E.O Gas sterilization process has been suitable for continuous production. Through validation, the sterilization process was deemed acceptable.
Also, the device's Shelf life of 3 years is validated in accordance with ISO 11607-1:2006 and ISO 11607-2:2006. Lastly, per ASTM D4169-22, it was confirmed that the product conforms with the requirements.
Conclusion 9.
The device is investigated for function to compare the operation of function between ACE Cannula and predicate devices. Test results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.
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Image /page/8/Picture/0 description: The image shows the logo for ACE, a company that focuses on safety. The logo is in blue and features a stylized lowercase "ace" with a slanted line above the "a". Below the logo, the tagline "For your safety" is written in a smaller font, emphasizing the company's commitment to safety.
Therefore, it is concluded that ACE Cannula is substantially equivalent to the legally marketed predicate
device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).