BD PERISAFE EPIDURAL ANESTHESIA TRAY
Device Facts
| Record ID | K953790 |
|---|---|
| Device Name | BD PERISAFE EPIDURAL ANESTHESIA TRAY |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | CAZ · Anesthesiology |
| Decision Date | Nov 30, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5140 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
It is the function of BD Perisafe™ Epidural Anesthesia Tray to contain all the necessary components to complete this procedure.
Device Story
BD Perisafe™ Epidural Anesthesia Tray contains procedural components for epidural anesthesia; includes needles, catheters, syringes, skin prep materials, and drug delivery accessories. Clinician performs procedure: cleans puncture site; anesthetizes topical tissue; inserts epidural needle using Loss of Resistance technique; inserts catheter; verifies placement via test dose; injects anesthetic; removes catheter post-procedure. Tray provides all necessary sterile components to facilitate these steps. Used in clinical settings by healthcare professionals.
Clinical Evidence
Bench testing only. Components conform to physical, mechanical, and biological specifications per ISO 594, ISO 7886, ISO 7864, and ISO 10993-1 standards.
Technological Characteristics
Tray contains sterile disposable needles, syringes, catheters, and skin prep components. Materials conform to ISO 594 (conical fittings), ISO 7886 (syringes), ISO 7864 (needles), and ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for patients requiring epidural anesthesia, including continuous or single-shot epidural procedures.
Regulatory Classification
Identification
An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.
Predicate Devices
- Kendall SafeTrak™ Continuous Epidural Anesthesia Tray (Catalog No. 5186)
- Abbott Continuous Epidural Anesthesia Tray (Catalog No. 11826-08)
- Burton® PERIFIX® Continuous Epidural Anesthesia Tray (Catalog No CE18TK-1OL)
- BD Perisafe™ Epidural Anesthesia Kit (Catalog No 405049)
Submission Summary (Full Text)
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# SUMMARY OF SAFETY AND EFFECTIVENESS
Becton Dickinson and Company
Perisafe™ Epidural Anesthesia Tray
# 1.0 BD CONTACT PERSON
Gregory Morgan, Manager
Regulatory Affairs
Phone (201)847-4344
Fax (201) 847-4868
Becton Dickinson and Company
Becton Drive, Building 2, MC226
Franklin Lakes, New Jersey 07417-1884
K953790
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# 2.0 DEVICE NAME
BD Perisafe™ Epidural Anesthesia Tray
# 3.0 PREDICATE DEVICE
Kendall SafeTrak™ Continuous Epidural Anesthesia Tray - Catalog No. 5186
Abbott Continuous Epidural Anesthesia Tray - Catalog No. 11826-08
Burton® PERIFIX® Continuous Epidural Anesthesia Tray - Catalog No CE18TK-1OL
BD Perisafe™ Epidural Anesthesia Kit - Catalog No 405049
Individual components
# 4.0 PRODUCT DESCRIPTION/ FUNCTION
4.1 Description - The BD Perisafe™ Epidural Anesthesia Tray
series will consist of several different trays. Each tray will include components that are needed to perform the epidural anesthesia procedure. There is some variation with respect to the anesthetic drugs and some of the procedural components.
4.2 Function - The subject device will function the same as predicate devices. The procedure for administering Epidural anesthetic is well documented and follows the steps briefly described below. These steps may vary slightly depending on whether the device is used to perform a continuous epidural or a single shot epidural.
Clean the immediate area around the puncture site.
Anesthetize the topical tissue of puncture site.
Insert the epidural needle and locate the epidural space through accepted technique (Loss of Resistance technique)
Insert the catheter through the epidural needle.
Verify correct catheter placement with a Test Dose injection or other accepted method.
Inject the epidural anesthetic into the epidural space.
Remove catheter at termination of procedure.
It is the function of BD Perisafe™ Epidural Anesthesia Tray to contain all the necessary components to complete this procedure.
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# SUMMARY OF SAFETY AND EFFECTIVENESS
Becton Dickinson and Company
Perisafe™ Epidural Anesthesia Tray
# 5.0 COMPARISON OF MODIFIED AND PREDICATE DEVICES EQUIVALENCE
# 5.1 Descriptive Comparison To a Legally Marketed Device
The components in subject device are similar to the predicate devices in all respects.
# 5.2 Performance Data Supporting Substantial Equivalence
Product specifications do not change from individually marketed devices.
All components conform to the physical mechanical and biological specifications found in the product standards referenced below.
ISO 594 Conical Fittings with a Luer Taper
ISO 7886 Sterile Disposable Syringes
ISO 7864 Sterile Disposable Needles
ISO 10993-1 Biological Evaluation of Medical Devices Part I: Guidance on Selection of Tests
# 5.3 Reference Table A For Comparison Table
This summary of Safety and Effectiveness data is being submitted in compliance with the Safe Medical Device Act.
# TABLE A
See next page
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# TABLE A
## COMPARISON TO A LEGALLY MARKETED DEVICE
BD PERISAFE™ CONTINUOUS EPIDURAL ANESTHESIA TRAY
| | SUBJECT DEVICE | PREDICATE DEVICES | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | BD - KIT 405040 | BRAUN CE18TK-10L | ABBOTT 4810-05 | KENDALL 5186 | |
| DRUGS AND AGENTS | SKIN WHEAL DRUG | 5 ml LIDOCAINE (1%) | N/A | 5 ml LIDOCAINE (1.5%) W/ 1:200,000 EPI | 5 ml LIDOCAINE (1.5%) W/ 1:200,000 EPI | N/A |
| | TEST DOSE | 5 ml LIDOCAINE (1.5%) W/ 1:200,000 EPI | N/A | 1ml 0.1% EPINEPHRINE | 1ml 0.1% EPINEPHRINE | N/A |
| | ADJUNCTIVE | N/A 10 ml 9% NaCl | N/A | 10 ml 9% NaCl | 10 ml 9% NaCl | N/A |
| SKIN PREP COMPONENTS | DRAPE | FENESTRATED | N/A | FENESTRATED ANT2 NON-FENESTRATED | FENESTRATED | FENESTRATED |
| | SPONGE APPLICATORS | 3 | N/A | 3 | 3 | 3 |
| | GAUZE PADS | 4 | N/A | 4 | 4 | 1 |
| | PREP TRAY | REMOVABLE | N/A | REMOVABLE | UPPER DECK | REMOVABLE |
| | TOWELS | 2 | N/A | 1 | 2 | |
| | IODINE | 30 ml POVIDONE | N/A | 30 ml POVIDONE | N/A | N/A |
| SKIN WHEAL COMPONENTS | SYRINGE | 3 ml PLASTIC u | N/A | 3 ml PLASTIC u | 3 ml PLASTIC u | 3 ml PLASTIC BL |
| | SYRINGE #2 | N/A | N/A | N/A | 1ml PLASTIC LS | N/A |
| | ASPIRATION FILTER | 19G x 1.5" NEEDLE | N/A | 4" FILTER SITLAW | N/A | 20G X 1.5" FILTER NEEDLE |
| | NEEDLE #1 | 22 G x 1.5" | N/A | 22G x 1.5" | 22G x 1.5" | 21G x 1.5" |
| | NEEDLE #2 | 25G x 1" | N/A | 25G x 5/8" | 25G X 5/8" | 25G X 5/8" |
| PROCEDURAL | NEEDLE #3 | N/A | | 18G x 1.5" | 18G x 1.5" | 18G X 1.5" |
| | PROCEDURAL NEEDLE #1 | 18G x 1.5" WEISS EPIDURAL | 18G x 1.5" WEISS EPIDURAL | 18G x 1.5" TOUHY-SCHLIPF EPIDURAL NEEDLE | 18G x 1.5" THINWALL EPIDURAL NEEDLE | 17G x 1.5" TOUHY-WEISS EPIDURAL NEEDLE |
| | CATHETER | 20G X 36" CLOSED - END CATH WITH GUIDE | 20G X 36" CLOSED - END CATH WITH GUIDE | 10G CLOSED TIP CATH WITH GUIDE | CATHETER WITH STYLET | 19G X 36" OPEN - END CATH WITH STYLET |
| | LOX SYRINGE | 5 ml GLASS SYRINGE u | 10 ml PLASTIC "LOX" SYRINGE LS | 113111 GLASS SYRINGE U | 10ml GLASS SYRINGE U | 5 ml GLASS SYRINGE LS |
| | EPIDURAL PROCEDURAL SYRINGE | 20 ml PLASTIC u | N/A | 20 ml PLASTIC U | N/A | 20 ml PLASTIC U |
| | CATHETER ADAPTERS | CATHETER CONNECTOR W/ CAP | CATHETER CONNECTOR | CATHETER CONNECTOR | CATHETER ADAPTER WITH CAP | CATHETER ADAPTER WITH CAP |
| | CATHETER SUPPORT PAD | N/A | N/A | 1 | 1 | |
| | MEDICINE CUP | 50mL BASIN | N/A | 50mL BASIN | 50 ml REMOVABLE BASIN | REMOVABLE DRUG CUP |
| | MISCELLANEOUS | N/A | N/A | N/A | N/A | ADHESIVE BANDAGE |
| | FILTERS | 2 MICRON | 2 MICRON W/ CAP | 2 MICRON | 2 MICRON | 2 MICRON |
The BD tray is one example of a series of Epidural Anesthesia trays.
