(93 days)
No
The 510(k) summary describes a mechanical device for syringe filling and access, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is described as a syringe filling device and a blunt plastic cannula used for accessing fluid paths for injection/aspiration of fluids, not for directly treating a disease or condition.
No.
The device facilitates the transfer of fluids (filling syringes, accessing vials/ampoules) and is designed to minimize risk associated with sharp needles. It does not perform any diagnostic function such as identifying a disease or condition or monitoring a physiological process.
No
The device description clearly outlines physical components (cannula, shield, cap) and the performance studies focus on physical characteristics and interactions (dose drawing, particulate matter, penetration force). There is no mention of software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in filling syringes from vials and ampoules and then using a blunt cannula for injection/aspiration of fluids. This is a process related to administering substances to a patient, not performing tests on samples taken from the body to diagnose conditions.
- Device Description: The description details the components of the device (cannulas, shield, cap) and their physical characteristics. It doesn't mention any reagents, test strips, or other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the device's ability to draw doses, access vials and ampoules, and penetrate materials. These are functional performance tests related to the device's intended use in handling fluids for administration, not analytical performance tests for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device is clearly intended for the preparation and administration of substances, which falls under the category of medical devices used in patient care, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The syringe filling device replaces standard, sharp hypodermic needles and all other syringe filling devices and accessories for syringe filling from vials and ampoules. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access for injecting/aspiration of fluids. The blunt plastic cannula is intended for use with Abott Life SheildTM, McGaw SafelineTM and Baxter Interlink® systems. The B-D TWINPAK™ offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.
Product codes
FMI
Device Description
The B-D® TWINPAK™ is an assembly consisting of currently marketed and previously approved devices incorporated into a protective shield - TWINPAK comprises the following legally marketed devices.
- B-D Blunt Plastic Cannula [cleared for marketing 510(K) #K964654]
- Syringe Filling Device {SFD} This is a 20G x ½" steel cannula, which is exactly the same as legally marketed device by Becton Dickinson, B-D® Tubing Adapter, Reorder #8210.
Devices (1) and (2) without their respective original shields are assembled into a plastic shield, as shown in figure. A plastic cap is also placed over the syringe filling device. The TWINPAK™ can be sold by itself or with a syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Safety and Effectiveness
The syringe filling device was tested to demonstrate a general equivalency in safety and effectiveness measures with predicate devices. Following lests were conducted as measures of safety and effectiveness for the intended use/application:
a. Dose drawing
b. Vial Stopper Particulate Matter
c. Vial Stopper Access
d. Ampoule Access
Equivalence Testing:
The following table lists specific tests used to demonstrate general equivalence for the Syringe Filling Device (SFD) to predicate devices when aspirating fluids.
a. Dose Drawing
b. Vial Stopper Particulate Matter
c. Vial Stopper Access
d. Ampoule Access
Dose Drawing - Test Description: Cannula are attached to a syringe. Air is aspirated into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1 mi doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is withdrawn. The fluid is measured using the scale of the syringe. The measurement tolerance for the single dose vials was +/- 0.2cc and for the multiple dose vial was +/- 0.1cc. This test is designed to determine if the cannula geometry allows for the full dose to be withdrawn from the vial and to determine equivalence with predicate devices. Thirty vials per cannula type were tested.
Conclusion - The SFD is equivalent for dose drawing to the predicate devices and the full dose can be withdrawn.
Vial Stopper Particulate Matter - Test Description: Cannula are attached to a syringe. Air is aspirated Into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1ml doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is withdrawn. The fluid is measured using the scale of the syringe. The fluid in the syringe is dispensed into a filter. The filters were than examined for visible stopper particulate matter. This test is designed to determine if vial stopper particulate matter is generated with the SFD and predicate devices. Thirty vials per cannula type were tested.
Conclusions - The SFD is equivalent to the predicate devices for generation of vial stopper particulate matter during vial access.
Vial Stopper Access - Test Description: Cannula are attached to a syringe. Air is aspirated into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1ml doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is aspirated. During pressunzation and aspiration any leakage was noted. Leakage is defined as fluid dripping. This test is designed to determine if equivalent vial stopper leakage occurs while aspirating fluids with the SFD and predicate devices. Thirty single dose vials were penetrated one time each for a total of 30 penetrations per cannula type. Thirty multiple dose vials were penetrated ten times each for a total of 300 penetrations per cannula type.
Conclusions - The SFD is equivalent for vial stopper access to the predicate devices.
Ampoule Access: The ability to access ampoules was assessed by a dimensional comparison between the SFD cannula geometry and ampoule dimensions as defined by ISO 9187-1 (Injection equipment for medical use - Ampoules for Injectables) and ISO 9187-2 (Injection equipment for medical use - One-point-cut ampoules). The criteria to determine that the SFD could access an ampoule was if the SFD cannula was longer than the shoulder length of the ampoule. If the cannula lenath is greater than the shoulder length then fluids would be able to be aspirated using normal protocols The SFD cannula length is greater than the shoulder length for all ampoules identified under nominal dimensions. This evaluation was intended to show equivalence for accessing ampoules with the SFD and predicate devices.
Conclusion - The SFD is equivalent to the predicate device for the ability to access ampoules.
Testing to Support Specific Claims:
CLAIM 1: SFD cannula is 10 times less sharp than an equivalent gauge standard hypodermic needle.
Study type: Penetration force testing in Dental Dam.
Test Description: Cannula were attached to a force transducer and penelrated through cannout were attached to chone Peak penetration forces were recorded. The sample size was 30 cannula per cannula type.
Conclusions: The SFD is 10 limes less sharp than an equivalent gauge standard hypodermic needle.
CLAIM 2: Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula.
Study type: Penetration force testing in various vials.
Test Description: Cannula were attached to a force transducer and penetrated through various drug vial stoppers in an axial direction. Peak penetration forces were recorded. The sample size was 30 cannula per cannula type.
Conclusions: Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula.
Key Metrics
Not Found
Predicate Device(s)
Becton Dickinson Blunt Plastic Cannula and Tubing Adapter, K964654
Reference Device(s)
Pre-amendment device, K920422, K883538, Pre-amendment device
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
B-D Contact Person 1.0
10.00
4 424 . - - - - - - - - -
JAN 2 2 1998
Gregory W. Morgan Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson and Company 1 Becton Drive, Building 2 Franklin Lakes, NJ 07417-1884 (201) 847-4344 - Phone (201) 847-4855 - FAX
2.0 Device Name
Becton Dickinson TWINPAK TH
Predicate Device 3.0
Becton Dickinson Blunt Plastic Cannula and Tubing Adapter
Product Description/Function 4.0
Product Description 4.1
The B-D® TWINPAK™ is an assembly consisting of currently marketed and previously approved devices incorporated into a protective shield - TWINPAK comprises the following legally marketed devices.
- B-D Blunt Plastic Cannula {cleared for marketing 510(K) #K964654] 1.
-
- Syringe Filling Device {SFD} This is a 20G x ½" steel cannula, which is exactly the same as legally marketed device by Becton Dickinson, B-D® Tubing Adapter, Reorder #8210.
Devices (1) and (2) without their respective original shields are assembled into a plastic shield, as shown in figure. A plastic cap is also placed over the syringe filling device. The TWINPAK™ can be sold by itself or with a syringe.
4.2 Product Function
The syringe filling device replaces standard, sharp hypodermic needles and all other syringe filling devices and accessories for syringe filling from vials and ampoules. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access to fluid path for injection/aspiration of fluids. The B-D® TWINPAK™ offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.
1
Comparison of Modified and Predicate Devices -- Predicate, legally marked device; 5.0 The following products are referenced as predicate devices:
Device | 510(k) # |
---|---|
Becton Dickinson 20G hypodermic needle | Pre-amendment device |
Becton Dickinson Interlink® Vial Access | |
Cannula | K920422 and K883538 |
Becton Dickinson Tubing Adapter | Pre-amendment device |
These products are compared to the syringe filling device of B-D® TWINPAK™.
5.1 Design
いよノ ムリノ ロロ
エレ・エレ
The syringe filling device is a standard 20G x 1/2" steel cannula. The cannula has a ground blunt point geometry with 45" bevel. This is exactly the same design as B-D Tubing Adapter,
5.2 Material
Material Comparison to Predicate Devices
Syringe Filling Device | B-D Tubing Adapter | B-D Hypodermic Needle | |
---|---|---|---|
Cannula | Stainless Steel | Stainless Steel | Stainless Steel |
Lubricant | Silicone | Silicone | Silicone |
AK Shield | Polypropylene | N/A | N/A |
Cap | Polypropylene | N/A | N/A |
Cannula hub | Polypropylene | Polypropylene | Polypropylene |
Adhesive | Epoxy | Epoxy | Epoxy |
5.3 Manufacturing Process
The manufacturing process used for the syringe filling device is exactly the same as that of B-D Precision Glide Needle and B-D Tubing Adapter. The process includes cannulating the steel cannula to molded plastic hub using epoxy adhesive. The TWINPAK™ shield and cap are manufactured by injection molding.
5.4 Product Use
The syringe filling device component of B-D® TWINPAK™ is for use in drawing up fluids/medications from vials and ampoules without requiring other accessories. Standard B-D hypodermic needle is also used for the same use. B-D Interlink® Vial Access Cannula is for use in drawing up medications from single dose vials only. The syringe filling device is comparable to predicate devices in dose drawing, vial penetration forces, vial stopper leakage and particulate matter generation.
ﻤﺴﺎﻧﺪ
2
Safety and Effectiveness ર્સ્ડ
- 5.5.1 The syringe filling device was tested to demonstrate a general equivalency in safety and effectiveness measures with predicate devices. Following lests were conducted as measures of safety and effectiveness for the intended use/application:
- a. Dose drawing
- b. Vial Stopper Particulate Matter
- c. Vial Stopper Access
- d. Ampoule Access
6.0 Equivalence
۳ ۱۰ ۱۰ ۱
いんしたいい
Testing to Support General Equivalence 6.1
The following table lists specific tests used to demonstrate general equivalence for the Syringe Filling Device (SFD) to predicate devices when aspirating fluids.
- a. Dose Drawing
- b. Vial Stopper Particulate Matter
- c. Vial Stopper Access
- d. Ampoule Access
Dose Drawing - Test Description 6.1.1
Cannula are attached to a syringe. Air is aspirated into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1 mi doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is withdrawn. The fluid is measured using the scale of the syringe. The measurement tolerance for the single dose vials was +/- 0.2cc and for the multiple dose vial was +/- 0.1cc. This test is designed to determine if the cannula geometry allows for the full dose to be withdrawn from the vial and to determine equivalence with predicate devices. Thirty vials per cannula type were tested.
Conclusion - The SFD is equivalent for dose drawing to the predicate devices and the full dose can be withdrawn.
Vial Stopper Particulate Matter - Test Description 6.1.2
Cannula are attached to a syringe. Air is aspirated Into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1ml doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is withdrawn. The fluid is measured using the scale of the syringe. The fluid in the syringe is dispensed into a filter. The filters were than examined for visible stopper particulate matter. This test is designed to determine if vial stopper particulate matter is generated with the SFD and predicate devices. Thirty vials per cannula type were tested.
ﻜﺴﺎ
3
Conclusions - The SFD is equivalent to the predicate devices for generation of vial stopper particulate matter during vial access.
Vial Stopper Access - Test Description 8.1.3
Cannula are attached to a syringe. Air is aspirated into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1ml doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is aspirated. During pressunzation and aspiration any leakage was noted. Leakage is defined as fluid dripping. This test is designed to determine if equivalent vial stopper leakage occurs while aspirating fluids with the SFD and predicate devices. Thirty single dose vials were penetrated one time each for a total of 30 penetrations per cannula type. Thirty multiple dose vials were penetrated ten times each for a total of 300 penetrations per cannula type.
Conclusions - The SFD is equivalent for vial stopper access to the predicate devices.
8.1.4 Ampoule Access
エレ、ニレ
い上ノムリノ ロリ
The ability to access ampoules was assessed by a dimensional comparison between the SFD cannula geometry and ampoule dimensions as defined by ISO 9187-1 (Injection equipment for medical use - Ampoules for Injectables) and ISO 9187-2 (Injection equipment for medical use - One-point-cut ampoules). The criteria to determine that the SFD could access an ampoule was if the SFD cannula was longer than the shoulder length of the ampoule. If the cannula lenath is greater than the shoulder length then fluids would be able to be aspirated using normal protocols The SFD cannula length is greater than the shoulder length for all ampoules identified under nominal dimensions. This evaluation was intended to show equivalence for accessing ampoules with the SFD and predicate devices.
Conclusion - The SFD is equivalent to the predicate device for the ability to access ampoules.
7.0 Testing to Support Specific Claims
The following table lists tests used to support specific claims beyond general equivalence.
| CLAIM
1 | SFD cannula is 10 times less
sharp than an equivalent gauge
standard hypodermic needle | Penetration force testing in
Dental Dam |
|------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| CLAIM
2 | Vial stopper penetration force is
substantially reduced when
comparing the SFD to the B-D
Vial Access Cannula | Penetration force testing in
various vials |
4
Penetration force testing in Dental Dam - Test Description 7.1
Cannula were attached to a force transducer and penelrated through cannout were attached to chone Peak penetration forces were recorded. The sample size was 30 cannula per cannula type.
Background
Dental Dam is a thin (.012 inches thick) latex rubber material that has been used to evaluate the penetration force of hypodermic and intravenous catheter needles. Peak penetration force is inversely proportional to the cannula sharpness, i.e. the higher the force, the less sharp the cannula.
Conclusions
The SFD is 10 limes less sharp than an equivalent gauge standard hypodermic needle.
- Penetration force testing into various vials Test Description 72
Cannula were attached to a force transducer and penetrated through various drug vial stoppers in an axial direction. Peak penetration forces were recorded. The sample size was 30 cannula per cannula type.
Conclusions
Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula.
20
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, connected by flowing lines. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IAN 2 2 1000
Mr. Gregory W. Morgan Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson & Company 1 Becton Drive, Building 2 07417-1884 Franklin Lakes, New Jersey
Re : K974006 Becton Dickinson Twinpak Trade Name: Regulatory Class: II Product Code: FMI Dated: December 8, 1997 Received: December 9, 1997
Dear Mr. Morgan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. . A . . . . . . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
6
Page 2 - Mr. Morgan
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-204% or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Page
510(k) Number (if known): | K974006 |
---|---|
Device Name: | Becton Dickinson TWINPAK™ |
Indications For Use: |
The syringe filling device replaces standard, sharp hypodermic needles and all other syringe The syringe filling device replaces standard, Sharp nypoules. Once the synings is a filling devices and accessories for synnge . The synnge is the restlached to the blunt filled, the filing device is deached into injociting spiration of fluids. The blunt plastic cannula is intended for use with Abott Life Shieline, McGaw Safeline in and Baster plastic cannula is imended for use with About the Convenion of deithering a syninge filling filling filling filling for any Interink® systems. The B-D TVVNPAR Oners the Conventorious of Controller of fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cuscinita
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 924000
Frescription Use_ (Per 21 CFR 801 . 109)
OR
Over-The-Counter Use .........................................
(Optional Format 1-2-96)
્રમું