(71 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of hypodermic needles, with no mention of AI or ML.
No
A therapeutic device is used to treat a condition. This device is a needle used to inject or withdraw fluids, which are procedures, not treatments in themselves.
No
Explanation: The device is a hypodermic needle intended for injecting or withdrawing fluids, not for diagnosing medical conditions. Its function is to facilitate the delivery or collection of substances, not to provide diagnostic information.
No
The device description clearly states it is a physical hypodermic needle made of stainless steel and polypropylene, which are hardware components. There is no mention of software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the needles are for "inject[ing] fluids into, or withdraw[ing] fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes on the patient, not for testing samples in vitro (outside the body).
- Device Description: The description details a hypodermic needle designed for connecting to a syringe, which is consistent with injecting or withdrawing fluids from a living organism.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) for the purpose of providing information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body itself in the way a hypodermic needle does.
N/A
Intended Use / Indications for Use
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall being Hypodermic Single Lumen Needles are sterile medical devices for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The design of the K-Pack II Needles has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards that have been established for hypodermic needles under FDA product code FMI and 21CFR Section 880.5570. The provided table lists acceptance criteria for tests including Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Conical fitting, Fluid leakage, Air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Stiffness test cannula, Resistance to breakage, Resistance to corrosion, Effective needle length, Silicon amount on cannula, Needle Penetration Resistance, Bonding strength between hub and cannula, Patency of Lumen, and Fitting strength hub/case.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cleanliness: When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under 2,5x magnification, the hub socket (fluid path surface) shall appear free from particles and extraneous matter.
Limits for acidity or alkalinity: △ pH for K-Pack Needles extract solution is within 1 unit of the control fluid according to EN ISO 7864.
Limits for extractable metals: The extract solution of the K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid according to EN ISO 7864: Σ Pb, Sn, Zn, Fe ≤ 5 mg/l; Cd
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 11, 2019 Terumo Europe N.V. M. Aerts VP Regulatory & Vigilance Interleuvenlaan 40 Leuven, 3001 Be
Re: K192057
Trade/Device Name: K-Pack II Needle - 27G x 1/2" Extra Thin Wall, K-Pack II Needle - 27G x 1/2" Ultra Thin Wall, K-Pack II Needle - 30G x 1/2" Extra Thin Wall, K-Pack II Needle - 30G x 1/2" Ultra Thin Wall Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 16, 2019 Received: September 23, 2019
Dear M. Aerts:
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
1
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 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 (QS) 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 medical devices and radiation-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,
For Alan 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
2
Indications for Use
510(k) Number (if known) K192057
Device Name
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 30G x 1/2" Extra Thin Wall, 30G x 1/2" Utra Thin Wall
Indications for Use (Describe)
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall being Hypodermic Single Lumen Needles are sterile medical devices for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Prepared for: | TERUMO EUROPE N.V.
Interleuvenlaan 40,
3001 Leuven,
BELGIUM |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Prepared by/Contact Person: | Mrs. M.J. Aerts – VP Regulatory & Vigilance
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
October 2019
Date prepared:
Note: Class III Summary & Certification is not applicable for the submission of a Class II device
4
II. 510(k) SUMMARY
- II.1. Submitter Information (807.92(a)(1))
- II.2. Device Name (807.92(a)(2))
- II.3. Predicate Devices (807.92(a)(3))
- II.4. Reason for Submission
- Device Description (807.92(a)(4)) II.5.
- Indications for Use (807.92(a)(5)) II.6.
- II.7. Substantial Equivalence Comparison (807.92(a)(6))
- Non Clinical Test (807.92(b)(1)) II.8.
- Clinical Test (807.92(b)(2)) II.9.
- II.10. Conclusion (807.92(b)(3))
5
II.1. Submitter Information (807.92(a)(1))
| Prepared for: | TERUMO EUROPE N.V.
Interleuvenlaan 40,
3001 Leuven,
BELGIUM |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared by/Contact person: | Mrs. M.J. Aerts – VP Regulatory & Vigilance
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
| Date prepared: | October 2019 |
| II.2. Device Name (807.92(a)(2)) | |
| Proprietary Name: | K-Pack II Needles –
27G x 1/2" Extra Thin Wall
27G x 1/2" Ultra Thin Wall
30G x 1/2" Extra Thin Wall
30G x 1/2" Ultra Thin Wall |
| Common Name: | Needle, Hypodermic, Single Lumen |
| Regulation Name: | Hypodermic single lumen needle |
21CFR, Section 880.5570
II.3. Predicate Devices (807.92(a)(3))
Regulation:
Product Code:
Classification:
The legally marketed device(s) to which substantial equivalence is claimed:
FMI
Class II
II.4. Reason for 510(k) Submission
This premarket notification [Special 510(k)] is being submitted for the K-Pack II Needles, manufactured by Terumo Europe N.V., for the following modification to the current device: the introduction of new product codes for K-Pack II Needles 27G & 30G x ½" with increased cannula's inner diameter and therefore different cannula wall type designation (ultra and extra thin wall vs thin wall).
Although there are no potential issues of safety and effectiveness for K-Pack II Needles with increased cannula's inner diameter, this Special 510k is being submitted due to the fact that the new cannula wall types are out of the range of the previously cleared needles.
This 510k will provide supporting information that the K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall are an acceptable extension of the current K-Pack II Needle product line.
II.5. Device Description (807.92(a)(4))
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Principle of Operation Technology
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall are operated manually or by manual process.
Design/Construction
The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.
Specifications
The following table shows the product codes, needle length and cannula wall type that are new for this submission.
| PRODUCT | NEEDLE | NEEDLE | NEEDLE | CANNULA | PACKAGING |
|---|---|---|---|---|---|
| CODE | GAUGE | LENGTH | BEVEL | WALL | |
| KN-2713RBKTE | 27 | 1/2" | regular | Extra Thin* | short case |
| KN-2713RBKTU | 27 | 1/2" | regular | Ultra Thin* | short case |
| KN-3013RBKE | 30 | 1/2" | regular | Extra Thin | short case |
| KN-3013RBKU | 30 | 1/2" | regular | Ultra Thin | short case |
- 27G: extra and ultra thin wall cannula specifications for a 27G needle are not defined in ISO 9626:2016. Therefore extra and ultra thin wall designation for the 27G K-Pack II Needles are based on Terumo internal specifications.
II.6. Indications for Use (807.92(a)(5))
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall being Hypodermic Single Lumen Needles are sterile medical devices for single use intended to inject fluids into, or withdraw fluids from. parts of the body below the surface of the skin.
Note: The intended use has not changed as a result of the modification. This is the same indication and intended use as the predicate devices, K-Pack II Needle - K984576 and 27G & 30G Thin Wall K-Pack II Needle - K110850.
II.7. Substantial Equivalence Comparison (807.92(a)(6))
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall, the subject of this Special 510(k), are substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following cleared devices:
Differences between the devices do not raise any significant issues of safety and effectiveness.
The similarities and differences are summarized in the table below.
7
| Characteristics | 27G x 1/2" Extra Thin Wall,
27G x 1/2" Ultra Thin Wall,
30G x 1/2" Extra Thin Wall
30G x 1/2" Ultra Thin Wall
K-Pack II Needle
(Terumo Europe, Belgium)
(Subject of this 510k) | 27G & 30G Thin Wall K-
Pack II Needles
(Terumo Europe, Belgium)
(K110850) | K-Pack II Needles
(Terumo Europe, Belgium)
(K984576) | Comments |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Same as predicate | Terumo Europe N.V. | Terumo Europe N.V. | Unchanged |
| Intended Use/
Indications for Use | Same as predicate | Intended to inject fluids into,
or withdraw fluids from, parts
of the body below the surface
of the skin. | Intended to inject fluids into,
or withdraw fluids from, parts
of the body below the surface
of the skin. | Unchanged |
| Materials | Same as predicate
Stainless Steel
Polypropylene
Epoxy glue
Silicone | Stainless Steel
Polypropylene
Epoxy glue
Silicone | Stainless Steel
Polypropylene
Epoxy glue
Silicone | Unchanged |
| Cannula | | | | |
| Hub | | | | |
| Glue | | | | |
| Lubricant | | | | |
| Design/
Constructions | Same as predicate | Comprised of a stainless steel
tube that is sharpened at one
end and at the other end
joined to a female luer
connector (hub) designed to
be connected with a male
connector (nozzle) of a piston
syringe. | Comprised of a stainless steel
tube that is sharpened at one
end and at the other end
joined to a female luer
connector (hub) designed to
be connected with a male
connector (nozzle) of a piston
syringe. | Unchanged |
| Specifications | 27G x 1/2" Extra Thin Wall,
27G x 1/2" Ultra Thin Wall,
30G x 1/2" Extra Thin Wall
30G x 1/2" Ultra Thin Wall | 27G x ½" Thin wall
30G x ½" Thin wall | Ranging from
18G – 27G
3/8" - 1 ½"
Regular & Thin wall | Increased cannula's
inner diameter and
therefore different
cannula wall type
designation (ultra and
extra thin wall vs thin
wall). |
| Principle of
Operation | Same as predicate | Manually | Manually | Unchanged |
| Unit packaging | Hard pack consisting of cap
and short case | Hard pack consisting of cap
and short case | Hard pack consisting of cap
and long or short case | Unchanged |
| Sterilization | EtO to SAL 10-6 | EtO to SAL 10-6 | EtO to SAL 10-6 | Unchanged |
| Shelf life | 5 years | 5 years | 5 years | Unchanged |
Substantial Equivalence Discussion
The subject K-Pack II Needles are the same needle as the cleared 27G & 30G Thin Wall Needle covered in K110850, the only difference is the introduction of new product codes for needles with increased cannula's inner diameter and therefore different cannula wall type designation (ultra and extra thin wall vs thin wall).
II.8. Non Clinical Test (807.92(b)(1))
Performance
The design of the K-Pack II Needles has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards that have been established for hypodermic needles under FDA product code FMI and 21CFR Section 880.5570:
8
EN ISO 7864:2016 "Sterile hypodermic needle for Single use"
EN ISO 9626: 2016''Stainless steel needle tubing for the manufacturing of medical devices"
EN ISO 80369-7: 2017 "Small bore connectors for liquids & gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
EN ISO 6009:2016 "Stainless steel needle tubing for the manufacturing of medical devices"
| Requirement | ACCEPTANCE CRITERIA |
|---|---|
| 1. Cleanliness | When inspected by normal or corrected-to-normal vision without magnification |
| under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle | |
| tube shall appear free from particles and extraneous matter | |
| When examined under 2,5x magnification, the hub socket (fluid path surface) shall | |
| appear free from particles and extraneous matter. | |
| 2. Limits for acidity or alkalinity | △ pH for K-Pack Needles extract solution is within 1 unit of the control fluid |
| according to EN ISO 7864. | |
| 3. Limits for extractable metals | The extract solution of the K-Pack II Needles has a content of extractable metals |
| which is, when corrected for the metal content of the control fluid according to EN | |
| ISO 7864: | |
| $Σ Pb, Sn, Zn, Fe ≤ 5 mg/l$ | |
| $Cd |