(36 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a hypodermic needle, with no mention of AI or ML.
No.
This device is a hypodermic needle used for injection and fluid removal, which are procedures, not therapies themselves. It's an instrument, not a treatment.
No
The device is described as a hypodermic needle for injecting and removing fluids. Its purpose is to facilitate the physical transfer of substances, not to provide information for diagnosis.
No
The device description clearly indicates it is a physical hypodermic needle made of stainless steel tubing with a hub and sharpened tip, intended for injection and removal of fluids. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the DepotOne device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection and removal of fluids from below the surface of the skin in humans." This describes a procedure performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The description details a hypodermic needle designed for physical interaction with the body (penetration of the skin) and connection to a syringe or administration set for fluid transfer.
- 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, etc.) to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze samples for diagnostic or other medical purposes. The DepotOne device is clearly intended for in vivo (within the body) procedures.
N/A
Intended Use / Indications for Use
DepotOne is a sterile single use hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The DepotOne needles comprise of a length of Hypodermic grade stainless steel tube connected to a female connector (hub) that is designed to mate with a male connector of a piston syringe or an intravascular administration set. The other end of the tube is sharpened with a lancet tip in accordance with ISO7864: 1993. The sharpened section of tube is of a reduced diameter. The fluid is injected or removed through a side aperture adjacent to the sharpened tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
DepotOne™ needles have passed the following tests:
Bend tests to EN ISO 9626:1995 Stainless Steel Tubing for the Manufacture of Medical Devices. (see note)
Breakage tests to EN ISO 9626:1995 Stainless Steel Tubing for the Manufacture of Medical Devices.
Needle/Hub Bond tests to EN ISO 7864:1993 Sterile Hypodermic Needles for Single Use.
Patency of Lumen tests to EN ISO 7864:1993 Sterile Hypodermic Needles for Single Use.
Extractables tests to EN ISO 7864:1993
Acidity and alkalinity tests to EN ISO7864: 1993
Additional tests: Fluid Flow Tests, Breakage tests for completed needles, Bend tests for complete needles includes the swaged tip, Penetration force tests.
None of the tests raised any issues relating to safety or effectiveness.
DepotOne™ needles have been subjected to and passed the following tests:
DepotOne needles are EO sterilised by a validated sterilisation method in accordance with the requirements of EN550. The sterilisation of DepotOne™ has been certified to comply with the requirements of EN556 and validated by an independent laboratory to a Sterility Assurance Level (SAL) of 106.
Bioburden test.
DepotOne needles have been tested for freedom of Pyrogens by means of LAL (limulus amebocyte lysate) test conducted by an independent laboratory in accordance with European Pharmacopoela.
A LAL test is performed on samples from every production batch/lot.
DepotOne needles have been tested for residual gas contents test in accordance with EN ISO10993-7. Limiting viewe 20mg ethylene oxide/24hrs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 a sequence of three triangles arranged horizontally. The triangles are oriented such that their bases are aligned vertically, and their apexes point to the right. The triangles are positioned adjacent to each other, creating a visual effect of progression or directionality from left to right.
APR 5 2005 Imprint Pharmaceut
Summary of Safety & Effectiveness for 510k Application
- I Imprint Contact Person: Mervyn Little Device Development Director Imprint Pharmaceuticals Ltd. 53 Langton Road East Molesey Surrey KT8 2HX Phone +44 208 224 9958 E-mail: Mervyn.Little@imprintpharma.com
- Device Name: DepotOne™ 2
- 3 Common Name: Hypodermic Needle
- 4 Classification Name: Hypodermic Single Lumen Needle (880.5570)
- 5 Predicate Device: K-Pack II Needle. Ref K984576
- 6 Product Description: Single use Hypodermic Needle.
- 7 Intended Use: DepotOne is a sterile single use hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans.
- 8 Description: The DepotOne needles comprise of a length of Hypodermic grade stainless steel tube connected to a female connector (hub) that is designed to mate with a male connector of a piston syringe or an intravascular administration set. The other end of the tube is sharpened with a lancet tip in accordance with ISO7864: 1993. The sharpened section of tube is of a reduced diameter. The fluid is injected or removed through a side aperture adjacent to the sharpened tip.
- 9 Substantial Equivalence: The DepotOne™ needles in this 510k submission are substantially equivalent in intended use, principles of operation and materials to the cleared K-Pack Hypodermic Single Lumen Needle that is the subject of K984576. The differences between the devices cited in this section do not raise any new safety issues or new issues relating to effectiveness.
1
Design & Materials:
DepotOne and K-Pack II needles are manufactured from stainless steel hypodermic grade tube.
The tip of DepotOne™ is reduced in diameter. An opening is ground into the side of the tube close to the sharpened tip to facilitate the delivery or removal of the fluids. The tip diameter of the K Pack II needle is not reduced, the opening is in the tip. Both needles are sharpened at the tip in accordance with ISO7864.
The proximal end of both needles is securely attached to a 6% Luer connector by means of an epoxy adhesive. The Luer connector is a locking fitting and is in accordance with ISO 594-2 (the K-Pack needle Luer connector does not completely meet the requirements of ISO 594-2). The connector is colour coded in accordance with ISO 6009.The DepotOne connector is manufactured from polycarbonate. The material differs from the material used in the predicate devices and was selected for its superior bond strength when glued. The difference in the materials does not have any impact on the sterilisation. The polycarbonate used in the manufacture of the hub is approved for EO and gamma sterilisation by the manufacturer.
Both needles are supplied fitted with a rigid moulded polypropylene needle tip protector (shield). The colour of this moulding is clear.
Both needles are sterilised using ethylene oxide (ETO).
The difference between DepotOne and the predicate device do not raise any significant issues of safety and effectiveness and do not affect the substantial equivalence.
| Product Code | Needle Gauge | Needle Length | Needle Bevel |
|---|---|---|---|
| D118021 | 23/18G XTW | 3/8" | Standard Lancet |
| D118022 | 23/18G XTW | ½" | Standard Lancet |
| D118023 | 23/18G XTW | 3/4" | Standard Lancet |
| D118024 | 23/18G XTW | 1" | Standard Lancet |
| D118025 | 23/18G XTW | 1 1/4" | Standard Lancet |
| D118026 | 23/18G XTW | 1 1/2" | Standard Lancet |
Proposed Product:
| Product Code | Needle Gauge | Needle Length | Needle Bevel |
|---|---|---|---|
| D118041 | 27/21G XTW | 3/8" | Standard Lancet |
| D118042 | 27/21G XTW | 1/2" | Standard Lancet |
| D118043 | 27/21G XTW | 3/4" | Standard Lancet |
| D118044 | 27/21G XTW | 1" | Standard Lancet |
| D118045 | 27/21G XTW | 1 ¼" | Standard Lancet |
| D118046 | 27/21G XTW | 1 ½" | Standard Lancet |
2
Materials:
| Component | Predicate K984576 | Proposed DepotOne™ |
|---|---|---|
| Cannulae | Stainless Steel | Stainless Steel |
| Hub (6% Locking Luer) | Polypropylene | Polycarbonate |
| Needle Lubricant | Silicone | Silicone |
| Adhesive | Epoxy | Epoxy |
| Sterilisation Method | ETO | ETO |
| Needle Shield | Polypropylene | Polypropylene |
Sterile Hypodermic Needles for Single Use. EN ISO 7864:1993
DepotOne™ conforms to the requirements of ISO 7864:1993 Sterile Hypodermic Needles for Single Use.
Tests
DepotOne™M needles have passed the following tests:
Bend tests to EN ISO 9626:1995 Stainless Steel Tubing for the Manufacture of Medical Devices. (see note) Breakage tests to EN ISO 9626:1995 Stainless Steel Tubing for the Manufacture of Medical Devices. Needle/Hub Bond tests to EN ISO 7864:1993 Sterile Hypodermic Needles for Single Use. Patency of Lumen tests to EN ISO 7864:1993 Sterile Hypodermic Needles for Single Use. Extractables tests to EN ISO 7864:1993 Acidity and alkalinity tests to EN ISO7864: 1993
Additional tests: Fluid Flow Tests, Breakage tests for completed needles, Bend tests for complete needles includes the swaged tip, Penetration force tests.
None of the tests raised any issues relating to safety or effectiveness.
Note:
DepotOne™ XTW needles have passed all the above tests. However it should be noted that ISO9626 (Stainless Steel Tubing for the Manufacture of Medical Devices) does not specify a maximum deflection for 1.2mm (18G) XTW tube or 0.8mm (21G) XTW tube (no data is presented in the standard).
The nearest data available is for 19G XTW and 22G XTW tube. The 1.2mm XTW tube passes the requirements for 1.1mm (19G) XTW tube and the 0.8mm XTW tube passes the requirements for 0.7mm (22G) XTW tube.
3
$\psi$ 45 $\psi$ 45 $\psi$ (4 of 4)
Sterilisation
DepotOne™ needles have been subjected to and passed the following tests:
DepotOne needles are EO sterilised by a validated sterilisation method in accordance with the requirements of EN550. The sterilisation of DepotOne™ has been certified to comply with the requirements of EN556 and validated by an independent laboratory to a Sterility Assurance Level (SAL) of 106.
Bioburden test.
DepotOne needles have been tested for freedom of Pyrogens by means of LAL (limulus amebocyte lysate) test conducted by an independent laboratory in accordance with European Pharmacopoela.
A LAL test is performed on samples from every production batch/lot.
DepotOne needles have been tested for residual gas contents test in accordance with EN ISO10993-7. Limiting viewe 20mg ethylene oxide/24hrs.
Conclusion
The DepotOne™ needles submitted in this 510k file are substantially equivalent in intended use, design principles, operation, and materials to the cleared K-Pack Single Lumen Needle that is subject to K984576.
The differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle are three curved lines that appear to be stylized representations of the human form. The logo is simple and clean, with a focus on the text and the abstract human figures.
APR 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Imprint Pharmaceuticals Limited C/O Mr. Tamas Borsai Responsible Third Party Official TUV Rheinland of North America, Incorporated 12 Commerce Road Newton, Connecticut 06470
Re: K050505
Trade/Device Name: DepotOne™ Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 17, 2005 Received: March 21, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your 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 cnactment date of the Medical Device merstate comments, or to devices that have been reclassified in accordance with the provisions of Anchuments, on to devrees and Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drug, and Connenay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls providents or annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device to subject to such additional controls. Existing major regulations affecting (FMA), It may be subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Seas nouncements concerning your device in the Federal Register.
5
Page 2 - Mr. Borsi
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 12 a determination that your device complies with other requirements mount that I Dr. Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal time Act's requirements, including, but not limited to: registration 1 ou intist compry wart 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 ce rear 801), equality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form nroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will are n you be begal finding of substantial equivalence of your device to a premarket notification. - The wice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rf you donto specifical of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chia-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Intended Use
K050505 510(k) Number DepotOne™ Device Name: DepotOne is a sterile hypodermic single Intended Use lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
(Optional Format 1-2-96)
J.M. V.M.
vision Sign-Off) in hion at Anesthasiology, General Hospital, Creenon Control. Dental Devices
: Number: K454545
3.1.1