(119 days)
No
The device description and performance studies focus on mechanical, sterility, and biocompatibility testing of a physical cannula, with no mention of AI or ML capabilities.
No
The device is described as being for injecting fluids, not for treating a disease or condition. It is a delivery mechanism, not a therapy in itself.
No
The device description and intended use clearly state that the ACE Cannula is used to inject fluids intradermally, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (needles, hub, cap, metal tube) and mentions bench testing related to mechanical properties, sterility, and biocompatibility, indicating it is a hardware device.
Based on the provided information, the ACE Cannula is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "inject fluids intradermally." This is a direct interaction with the patient's body for the purpose of delivering substances, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a device for injecting fluids, consisting of needles, a hub, and a cap. This aligns with a device used for administering substances, not for performing tests on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used with biological specimens (blood, urine, tissue, etc.), reagents, or for the purpose of generating diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. The ACE Cannula is designed to put substances into the body.
N/A
Intended Use / Indications for Use
The ACE Cannula is intended to inject fluids intradermally.
Product codes
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intradermally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
- 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)
- 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)
- 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
Chemical testing:
- Extraction: pH: Pass
- Extraction: Potassium permanganate reducing substances: Pass
- Extraction: Residue on evaporation: Pass
- Extraction: Pb, Fe, Sn, Zn: Pass
- Extraction: Cd: Pass
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 (
§ 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).
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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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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).
2
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
3
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 | 0.8000.830 |0.673 |
| AN-2325 | 23 | 25 | 0.600
| AN-2613 | 26 | 13 | 0.4400.470 |0.470 |
| AN-2625 | 26 | 25 | 0.440
| AN-2725 | 27 | 25 | 0.4000.420 |0.730 |
| B-2260 | 22 | 60 | 0.698
| B-2270 | 22 | 70 | 0.6980.730 |0.530 |
| B-2540 | 25 | 40 | 0.500
| B-2550 | 25 | 50 | 0.5000.530 |0.420 |
| B-2725 | 27 | 25 | 0.400
| B-2738 | 27 | 38 | 0.4000.420 |0.420 |
| B-2750 | 27 | 50 | 0.400
| 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: 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 | 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 (, Particulate Matter for Injections (Method 1 Light
Obscuration Particle Count Test). Test result should satisfy the
requirements described in the USP | 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 , Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| E.O sterilization validation | According to ISO 11135:2014 | |
| E.O 30%, CO2 70% | ||
| Temperature: 50 $\pm$ 7°C | ||
| Exposure 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 Micro | ||
| Cannula is intended to inject fluids | |||
| intradermally. | The Eclipse DermaFlex Cannula is intended to | ||
| inject fluids intradermally. | Identical | ||
| Principle of | |||
| Operation | This device is used in conjunction with a piston | ||
| syringe to deliver fluids/medications/drugs into | |||
| the body. The device consists of a metal | |||
| tube(needle), joined to a female | |||
| connector(hub). This device comes in a variety | |||
| of needle gauges and lengths. | This device is used in conjunction with a piston | ||
| syringe to deliver fluids/medications/drugs into | |||
| the body. The device consists of a metal | |||
| tube(needle), joined to a female | |||
| connector(hub). This device comes in a variety | |||
| of 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 for
single use - Requirements and test methods | Complies to the following standards:
ISO 7864 : 2016 Sterile hypodermic needles for
single use - Requirements and test methods | Identical |
| Needle
Performance
Requirements | ISO 9626 : 2016 Stainless steel needle tubing
for the manufacture of medical devices -
Requirements and test methods | ISO 9626 : 2016 Stainless steel needle tubing
for the manufacture of medical devices -
Requirements and test methods | Identical |
| Biocompatibility | Conforms to the requirements of ISO 10993
series standards. | Conforms to the requirements of ISO 10993
series 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.