(31 days)
The BD Eclipse™M Hypodermic Need for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.
The BD Eclipse™ Hypodermic Needle is a device that is composed of a typical hypodermic needle with a one piece hub/adapter and pivoting cover that is connected to the adapter. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal. These needles have a regular, short or intradermal bevel type. The needle assembly is protected with a polypropylene shield.
The Eclipse™ Hypodermic Needles are offered in a variety of gauge sizes (18-30 gauge) and needle length (½''- 1/2''). The needle hub is color-coded to the appropriate gauge needle per ISO 6009.
The BD Eclipse™ Hypodermic Needle hub incorporates a female 6% (Luer) connector which can be used with a compatible male 6% (Luer) connector. The BD Eclipse™ Hypodermic Needle is not to be used with luer-slip syringe as the needle may become disengaged from the syringe when activating the safety cover. This product is single use and provided sterile.
The change described in this submission is the replacement of current silicone based HCFC-containing needle lubricant with silicone based HCFC-free lubricant.
The provided document describes the FDA 510(k) summary for the BD Eclipse™ Hypodermic Needle (K161170). This document is for a medical device (hypodermic needle) and does not contain information related to an AI/ML powered device, nor does it describe a study involving human readers or ground truth established by experts/pathology for algorithm training or testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML powered device, as the document does not pertain to such a device.
The document discusses the substantial equivalence of the new BD Eclipse™ Hypodermic Needle (K161170) to a predicate device (K010188), primarily due to a change in the needle lubricant and some additional needle length/gauge sizes. The evaluations performed are typical for a conventional medical device modification, focusing on physical performance characteristics and biocompatibility.
Here's what can be extracted from the document, tailored as much as possible to the request, but highlighting the absence of AI-specific information:
Description of Acceptance Criteria and Studies (Conventional Device)
The device being reviewed is the BD Eclipse™ Hypodermic Needle, which is a conventional medical device (not AI-powered). The acceptance criteria and studies are related to the physical and functional performance of the needle, and its biocompatibility. The primary change in this submission is the replacement of a silicone-based HCFC-containing needle lubricant with an HCFC-free lubricant.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Met Internal BD Specification or Standard) | Reported Device Performance (Summary) |
|---|---|---|
| Functional Testing | ||
| Hub Color | Per ISO 6009 | Met ISO 6009 |
| Hub/Needle Bond Strength | Met internal BD specification | Met internal BD specification |
| Needle Penetration Test | Met internal BD specification | Met internal BD specification |
| Needle Shield Removal Forces | Met internal BD specification | Met internal BD specification |
| Leak Testing | Per ISO 594-2 | Met ISO 594-2 |
| Sterilization | ||
| Process | Per ISO 11135 | Performed per ISO 11135 |
| SAL Level | SAL 10-6 | SAL 10-6 |
| Shelf Life | ||
| Durability | 5 Years | Demonstrated 5 years |
| Biocompatibility | Per ISO 10993-1, including specific tests | Acceptable according to ISO 10993-1 |
| Safety Mechanism Performance | Predetermined acceptance criteria (e.g., activation/unlocking forces, impact resistance) | Met predetermined acceptance criteria |
| Cannula Pull-out Forces | Predetermined acceptance criteria | Met predetermined acceptance criteria |
| Ship Test | Predetermined acceptance criteria | Ensured needle/safety shield integrity |
| Risk Management | In accordance with ISO 14971 | Performed in accordance with ISO 14971 |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test mentioned (e.g., Hub/Needle Bond Strength, Needle Penetration Test). It refers to "validation/verification/verification activities" and "Design Verification activities." The data provenance is internal to Becton, Dickinson and Company's testing procedures. It is implicitly "prospective" in the sense that the new device (with the changed lubricant) was tested, but the data itself is from internal laboratory testing, not clinical trials or population data from specific countries.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable to this submission. The "ground truth" for a hypodermic needle's performance is established by objective engineering specifications, international standards (e.g., ISO), and internal company specifications, not by human experts adjudicating clinical or imaging data.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" in the context of physical performance testing of a hypodermic needle. Results are measured against predefined numerical or qualitative standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human interpretation is involved. This is a hypodermic needle.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an algorithm or AI-powered device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- International Standards: e.g., ISO 6009 for hub color coding, ISO 594-2 for leak testing, ISO 11135 for sterilization, ISO 10993-1 for biocompatibility, ISO 14971 for risk management.
- Internal BD Specifications: For characteristics like Hub/Needle Bond Strength, Needle Penetration Test, Needle Shield Removal Forces, cannula pull-out forces, activation/unlocking forces, impact resistance, and ship testing.
- Objective Measurements: Laboratory and engineering tests generate quantitative data that is compared against these predefined standards and specifications.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2016
Becton, Dickinson and Company Ms. Priyanka Apte Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K161170
Trade/Device Name: BD Eclipse™ Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 22, 2016 Received: April 28, 2016
Dear Ms. Apte:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161170
Device Name BD Eclipse™ Hypodermic Needles
Indications for Use (Describe)
The BD Eclipse™M Hypodermic Need for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.
| 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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510(k) Summary
| Submitted By: | Priyanka ApteRegulatory Affairs SpecialistBecton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Phone: (201)847-4608Fax: (201)847-5307 | |
|---|---|---|
| Date Prepared: | May 27, 2016 | |
| Subject Devices: | ||
| Trade Name: | BD EclipseTM Hypodermic Needle | |
| Common Name: | Hypodermic Single Lumen Needle | |
| Classification: | Class II, 21 CFR §880.5570, Hypodermic Single LumenNeedle | |
| Product Code: | FMI: Needle, Hypodermic, Single Lumen | |
| Predicate Devices: | ||
| Trade Name: | BD EclipseTM Hypodermic Needle | |
| 510(k) Reference: | K010188 | |
| Common Name: | Hypodermic Single Lumen Needle | |
| Classification: | Class II, 21 CFR §880.5570, Hypodermic Single LumenNeedle | |
| Product Code: | FMI: Needle, Hypodermic, Single Lumen |
Device Description
The BD Eclipse™ Hypodermic Needle is a device that is composed of a typical hypodermic needle with a one piece hub/adapter and pivoting cover that is connected to the adapter. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal. These needles have a regular, short or intradermal bevel type. The needle assembly is protected with a polypropylene shield.
The Eclipse™ Hypodermic Needles are offered in a variety of gauge sizes (18-30 gauge) and needle length (½''- 1/2''). The needle hub is color-coded to the appropriate gauge needle per ISO 6009.
The BD Eclipse™ Hypodermic Needle hub incorporates a female 6% (Luer) connector which can be used with a compatible male 6% (Luer) connector. The BD Eclipse™ Hypodermic Needle is not to be used with luer-slip syringe as the needle may become disengaged from the syringe when activating the safety cover. This product is single use and provided sterile.
The change described in this submission is the replacement of current silicone based HCFC-containing needle lubricant with silicone based HCFC-free lubricant.
Intended Use
The BD Eclipse™ Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes.
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The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Technological Characteristics
The subject BD Eclipse™ Hypodermic Needles are equivalent to that of the predicate BD Eclipse™ Hypodermic Needles in intended use, fundamental scientific technology, operating principles, product design, and performance characteristics.
| Device Characteristics | Subject DeviceBD Eclipse™ Hypodermic | Predicate DeviceBD Eclipse™ Hypodermic |
|---|---|---|
| Needle (K161170) | Needle (K010188) | |
| Manufacturer | Becton, Dickinson and Company | Becton, Dickinson and Company |
| Intended Use | The BD Eclipse™ HypodermicNeedle is used for generalpurpose injection and aspirationof fluid from vials, ampoules andparts of the body below thesurface of the skin. The BDEclipse Hypodermic Needle iscompatible for use with standardluer-lock syringes.The BD Eclipse™ HypodermicNeedle contains a mechanismthat covers the needlepoint afteruse. In the activated position theneedle cover guards againstaccidental needle sticks duringnormal handling and disposal ofthe used needle/syringecombination. | The BD Eclipse™ HypodermicNeedle is used for generalpurpose injection and aspirationof fluid from vials, ampoules andparts of the body below thesurface of the skin. The BDEclipse Hypodermic Needle iscompatible for use with standardluer-slip and luer-lock syringes.The BD Eclipse™ HypodermicNeedle contains a mechanismthat covers the needlepoint afteruse. In the activated position theneedle cover guards againstaccidental needle sticks duringnormal handling and disposal ofthe used needle/syringecombination. |
| Operating Principle | BD Eclipse™ HypodermicNeedles are devices that arecomposed of a typicalhypodermic needle with a onepiece hub/adapter and pivotingcover that is connected to theadapter. The device consists of amechanism that covers the needlepoint after use | BD Eclipse™ HypodermicNeedles are devices that arecomposed of a typicalhypodermic needle with a onepiece hub/adapter and pivotingcover that is connected to theadapter. The device consists of amechanism that covers the needlepoint after use |
| Materials | Hub: PolypropyleneCannula: Stainless SteelCannula Lubricant: HCFC-freesiliconeNeedle/Safety Shield: | Hub: PolypropyleneCannula: Stainless SteelCannula Lubricant: HCFCcontaining siliconeNeedle/Safety Shield: |
| Polypropylene | Polypropylene | |
| Packaging | Blister Pouch | Blister Pouch |
| Shelf Carton | Shelf Carton | |
| Case Carton | Case Carton | |
| Specification | Needle Length: ½'' - 1½'' | Needle Length: ½'' - 2'' |
| Needle Gauge: 18-30 Gauge | Needle Gauge: 18-25 Gauge | |
| Bevel: Regular, Short,Intradermal | Bevel: Regular, Short,Intradermal | |
| Functional Testing | Hub Color: Per ISO 6009 | Hub Color: Per ISO 6009 |
| Hub/Needle Bond Strength: Metinternal BD specification | Hub/Needle Bond Strength: Metinternal BD specification | |
| Needle Penetration Test: Metinternal BD specification | Needle Penetration Test: Metinternal BD specification | |
| Needle Shield Removal Forces:Met internal BD specification | Needle Shield Removal Forces:Met internal BD specification | |
| Leak Testing: Per ISO 594-2 | Leak Testing: Per ISO 594-2 | |
| Sterilization | Per ISO 11135 | Per ISO 11135 |
| SAL Level | SAL 10-6 | SAL 10-6 |
| Shelf Life | 5 Years | 5 Years |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 |
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Performance Data
Additional length /gauge size have been validation/verification/verification activities which included cannula pull out forces to ensure hub/cannula bonding, activation/unlocking forces, impact resistance to ensure safety mechanism of a needle and a ship test to ensure needle/safety shield integrity. The results of all these tests either met the predetermined acceptance criteria and BD's internal specification or performed to the standard.
Modifications proposed to BD Eclipse™ Hypodermic Needle evaluated using risk management plan. This risk assessment process is performed in accordance with ISO14971. Biocompatibility testing included cytotoxicity (per ISO10993-5), hemolysis (per ISO10993-4), acute systemic toxicity (per ISO10993-11), intracutaneous reactivity (per ISO10993-10), sensitization (per ISO10993-10), pyrogenicity (per ISO 10993-11) and chemical extractable analysis (per ISO 10993-18). The results were acceptable according to ISO 10993-1.
Design Verification activities such as Needle Penetration Test, Hub/Needle Bond Strength, Leak Testing and Needle Shield Removal Forces were performed to demonstrate that the subject device met BD's internal predetermined acceptance criteria.
The results of these activities mentioned in table above (Risk Management, Biocompatibility and Design Verification activities) either met BD's internal specification or performed according to the standard.
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Thus these activities demonstrated that the subject device is substantially equivalent to the predicate device.
Substantial Equivalence
The subject BD Eclipse™ Hypodermic Needle has the same intended use, fundamental scientific technology and operating principles when compared to the predicate BD Eclipse™ Hypodermic Needle and is substantially equivalent to its legally marketed predicate K010188.
Conclusion
The BD Eclipse™ Hypodermic Needles have been verified to meet the established performance criteria above. The results of design verification testing demonstrate that the BD Eclipse™ Hypodermic Needles perform as intended and perform as well as 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).