K Number

Device Name

BD Epilor Syringe

Manufacturer

Becton Dickinson and Company

Date Cleared

2022-05-19

(413 days)

Product Code

CAZ

Regulation Number

868.5140

Intended Use

BD Epilor™ syringes are intended for use with either air or liquid in conjunction with an epidural needle for identifying the epidural space. These types of syringes facilitate the "loss of resistance" technique for identifying the epidural space by reducing subjectivity when locating this space and the potential for complications when administering epidural anesthesia to patients. Not for spinal applications. These devices are intended for adult and pediatric patients.

Device Description

The subject BD Epilor™ (Loss of Resistance Syringe) is used in various types of epidural anesthesia procedures. The purpose of this syringe is to help the anesthesiologist locate the epidural space prior to administering either single shot or continuous epidural anesthesia. The syringe assembly consists of a lubricated polypropylene barrel imprinted with a graduated scale, a polypropylene plunger rod, and a silicone rubber stopper which is a double-ribbed to prevent leakage. BD Epilor ™ is used in conjunction with an epidural needle for the purpose of identifying the epidural space. BD Epilor™ syringes are available in 7ml sizes and supplied in plastic configurations and as sterile or Bulk Non-Sterile.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K925902

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "loss of resistance" technique is a manual method facilitated by the syringe's design.

Therapeutic

No.
The device is described as facilitating the "loss of resistance" technique for identifying the epidural space and assisting in locating the epidural space prior to administering anesthesia, rather than directly treating a disease or condition.

Diagnostic

The device is used to help locate the epidural space, a physical act, not to diagnose a condition or disease. It facilitates a technique for administering anesthesia.

SaMD (Software as a Medical Device)

The device description clearly states it is a syringe assembly consisting of physical components like a barrel, plunger rod, and stopper. The performance studies also focus on physical properties and biocompatibility, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, the BD Epilor™ syringe is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to facilitate the "loss of resistance" technique for identifying the epidural space in conjunction with an epidural needle. This is a procedure performed directly on a patient's body to locate an anatomical space.
Device Description: The device is a syringe used to inject air or liquid into the epidural space. It's a tool for a medical procedure, not for testing samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BD Epilor™ syringe does not fit this definition. It's a medical device used in a procedural context.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

CAZ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

epidural space

Indicated Patient Age Range

adult and pediatric patients.

Intended User / Care Setting

anesthesiologist

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)

BD has performed the following non-clinical/design verification testing based on the risk analysis conducted and the results of these tests demonstrate that the BD EpilorTM performed in an equivalent manner to the predicate device per ISO 594-1 and 594-2 for:

LL Separation Force
Unscrewing Torque
Overriding Torque
Luer Leakage – Positive Pressure Decay
Sub-Atmospheric Pressure Air Leakage
Stress Cracking
Per BD internal requirements for:
Ink Permanency
Fit Test
Stopper Leakage
A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018. Based on the evaluation, the following biological tests were conducted:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Material- mediated pyrogenicity
Hemolysis
Chemical Extractables Analysis
Additionally, the following tests were performed:
Particulate Matter per USP .
The device is sterilized using ethylene oxide process and was validated per ISO 11135.
Per the design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.

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.

K925902

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

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

May 19, 2022

Becton Dickinson and Company Huwien Yang Senior Regulatory Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K210983

Trade/Device Name: BD Epilor Syringe Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia conduction kit Regulatory Class: Class II Product Code: CAZ Dated: April 15, 2022 Received: April 18, 2022

Dear Huwien Yang:

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 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 and Part 809); 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 mediation-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,

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K210983

Device Name BD Epilor™ Syringe

Indications for Use (Describe)

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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K210983

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Submitter

Information

Premarket Notification - Traditional Section 7 – 510K Summary

510(k) Summary (21 CFR §807.92) BD Epilor™ Syringe

Submitter Name:	Becton, Dickinson and Company
Submitter Address:	1 Becton Drive
	Franklin Lakes, NJ 07417
Contact Person:	Huiwen Yang
	Senior Regulatory Affairs Specialist
Email Address:	Huiwen.yang@bd.com
Phone Number:	Phone: (201) 847-4408
	Fax: (201) 847-5397

	Email Address:	Huiwen.yang@bd.com
	Phone Number:	Phone: (201) 847-4408
	Fax Number:	Fax: (201) 847-5307
	Date of
Preparation:	April 15, 2022
Subject Device	Trade Name:	BD Epilor™ Syringe
	Common Name:	Loss of Resistance Syringe
	Regulation
Number:	21 CFR §868.5140
	Regulation Name:	Anesthesia Conduction Kit
	Regulatory Class:	Class II device
	Product Code:	CAZ (Anesthesia Conduction Kit)
	Classification Panel:	Anesthesiology
Predicate
Device	Trade Name:	B-D Loss of Resistance Syringe
	510(k) Reference:	K925902
	Common Name:	Loss of Resistance Syringe
	Regulation
Number:	21 CFR §868.5140
	Regulation Name:	Anesthesia Conduction Kit
	Regulatory Class:	Class II device
	Product Code:	CAZ (Anesthesia Conduction Kit)
	Classification Panel:	Anesthesiology
Reason For
Change	The purpose of the submission is to re-baseline the Predicate
device B-D Loss of Resistance Syringe.
Device
Description	The subject BD Epilor™ (Loss of Resistance Syringe) is used in
various types of epidural anesthesia procedures. The purpose of
this syringe is to help the anesthesiologist locate the epidural
space prior to administering either single shot or continuous
epidural anesthesia. The syringe assembly consists of a
lubricated polypropylene barrel imprinted with a graduated
scale, a polypropylene plunger rod, and a silicone rubber
stopper which is a double-ribbed to prevent leakage. BD

Premarket Notification - Traditional Section 7 – 510K Summary

| | Epilor ™ is used in conjunction with an epidural needle for the
purpose of identifying the epidural space. BD Epilor™ syringes
are available in 7ml sizes and supplied in plastic configurations
and as sterile or Bulk Non-Sterile. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | BD Epilor™ syringes are intended for use with either air or
liquid in conjunction with an epidural needle for identifying the
epidural space. These types of syringes facilitate the “loss of
resistance” technique for identifying the epidural space by
reducing subjectivity when locating this space and the potential
for complications when administering epidural anesthesia to
patients. These devices are intended for adult and pediatric
patients. |

Technological Characteristics

The subject devices are equivalent to the predicate devices in intended use, materials and performance characteristics:

| Element of

Comparison	Subject Device	Predicate Device	Comparison
510K #	K210983	K925902	Not applicable
Indications for
Use/Intended
Use	BD Epilor™ syringes
are intended for use
with either air or liquid
in conjunction with an
epidural needle for
identifying the epidural
space. These types of
syringes facilitate the
"loss of resistance"
technique for
identifying the epidural
space by reducing
subjectivity when
locating this space and
the potential for
complications when
administering epidural
anesthesia to patients.
Not for spinal
application,	B-D Loss of Resistance
Syringe is used in
combination with an
Epidural Needle in the
first phase of the
Epidural Anesthesia
Procedure. The "loss of
resistance" technique in
epidural anesthesia is
used for identifying the
epidural space prior to
administration of
medication or
placement of an
Epidural Catheter. By
attaching a LOR
Syringe filled with air or
saline to the epidural
needle the clinician can
identify arrival of the
needle tip in the
epidural space by a
dramatic Loss of
Resistance to syringe
plunger movement.	Equivalent,
the
indications for
use/intended
use has been
modified to
provide better
clarity.

Premarket Notification - Traditional

	Barrel	Polypropylene	Polypropylene	same
Syringe materials	Barrel
Lubricant	Silicone	Silicone	same
	Plunger
Rod	Polypropylene+Colorant
(Blue)	Polypropylene+Colorant
(Blue)	same
	Stopper	Self- lubricated silicone	Self-lubricated silicone	same
	Stopper
Lubricant	Silicone	Silicone	same
	Barrel ink	Black Ink	Black Ink	same
	Syringe Type	3 Pieces (barrel,
stopper and plunger)	3 Pieces (barrel,
stopper and plunger)	same
Tip type		Luer-Lok™ or Luer Slip
per ISO 594-1: 1986
and ISO 594-2:1998
7mL	Luer-Lok™ or Luer Slip
per ISO 594-1: 1986
and ISO 594-2:1998
3mL, 5mL, 10mL ,
20mL	Equivalent;
Only 7mL BD
Epilor™
syringes are
offered
Dose
Setting/Volumes
	Sterilization
Method	Ethylene Oxide	Ethylene Oxide	same
	SAL	10-6	10-6	same
Shelf Life		5 Years	5 Years	same

	Functional Tests
	Ink Permanency	Per BD internal
requirements	Per BD internal
requirements	same
Luer-Lok
Separation
Force		Meets ISO 594-2
requirement;	Meets ISO 594-2
requirement;	same
Luer Slip
Separation force		Meets ISO 594-1
requirement	Meets ISO 594-1
requirement	same
	Unscrewing
Torque(Luer-
Lok)	Meets ISO 594-2
requirement	Meets ISO 594-2
requirement	same
	Resistance to
Overriding
(Luer-Lok)	Meets ISO 594-2
requirement	Meets ISO 594-2
requirement	same
Luer Leakage -
Positive
Pressure Decay
(Luer-Lok and		Meets ISO 594-1 and
594-2 requirement	Meets ISO 594-1 and
594-2 requirement	same
Luer-Slip )
Sub-
Atmospheric
Pressure Air
Leakage (Luer-
Lok and Luer-
Slip )	Meets ISO 594-1 and
594-2 requirement	Meets ISO 594-1 and
594-2 requirement	same
Stress Cracking	Meets ISO 594-1 and
594-2 requirement	Meets ISO 594-1 and
594-2 requirement	same
Fit Test	Meet BD internal
requirements	Meet BD internal
requirements	same
Stopper
Leakage	Meet BD internal
requirements	Meet BD internal
requirements	Same
Biocompatibility tests
Cytotoxicity	Per ISO 10993-5, ISO
10993-12, & USP
:
Non-cytotoxic	Non-cytotoxic	Equivalent
Sensitization	Per ISO 10993-10:
Non-sensitizer	Non-sensitizer	Equivalent
Intracutaneous
Reactivity	Per AAMI ISO 10993-10
& USP:
Non-irritant	Non-irritant	Equivalent
Acute Systemic
Toxicity	Per ISO 10993-11 &
USP :
Non-toxic	Non-toxic	Equivalent
Material-
mediated
Pyrogenicity	Per ISO 10993-
11:2017 & USP:
Non-pyrogenic	Non-pyrogenic	Equivalent
Extractables/
Leachables	Per ISO 10993-18:
Acceptable	Heavy metal tests;
Pass	Equivalent
Hemolysis	Per ISO 10993-4, ASTM
Guideline F619-14,
ASTM Guideline F756-
17:Non-hemolytic	Non-hemolytic	Equivalent
Additional Tests:
Particulate
Matter	Per USP 788:
Particulate number is
under the limit.	Below the limit	Equivalent
Performance
Tests	BD has performed the following non-clinical/design verification
testing based on the risk analysis conducted and the results of
these tests demonstrate that the BD EpilorTM performed in an

Premarket Notification - Traditional

Premarket Notification - Traditional Section 7 – 510K Summary

equivalent manner to the predicate device.

Per ISO 594-1 and 594-2:

LL Separation Force ●
Unscrewing Torque ●
Overriding Torque ●
Luer Leakage – Positive Pressure Decay
Sub-Atmospheric Pressure Air Leakage ●
Stress Cracking ●

Per BD internal requirements:

Ink Permanency ●
Fit Test
Stopper Leakage ●

A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted:

Cytotoxicity ●
Sensitization ●
Intracutaneous Reactivity ●
Acute Systemic Toxicity
Material- mediated pyrogenicity ●
Hemolysis
Chemical Extractables Analysis ●

Additionally, the following tests were performed:

Particulate Matter per USP .
The device is sterilized using ethylene oxide process and was validated per ISO 11135.

Per the design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.

Clinical Testing

Clinical testing was not required for the subject device this submission.

Premarket Notification - Traditional

| Summary of
Substantial
Equivalence | Based on the intended use, technological characteristics and
performance testing, the subject device meets the
requirements that is considered sufficient for its intended use.
Therefore, BD EpilorTM syringe is substantially equivalent to the
predicate device in principles of operation, technology, design,
materials and performance. The indications for use/intended
use has been modified to provide better clarity. |

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