The Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.

The Spinocan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.

Device Description

The B. Braun Pencan Spinal Needle consists of a polycarbonate hub bonded to a stainless steel cannula with pencil-point tip. The hub of the Pencan spinal needle incorporates a viewing window for visualization of cerebrospinal fluid. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 22 Ga. to 27 Ga. Needles that are 24 Ga .- 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.

The B. Braun Spinocan Spinal Needle consists of the same polycarbonate hub as the Pencan needles. The hub is bonded to a stainless steel cannula with Quincke bevel. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 18 Ga. to 27 Ga. Needles that are 25 Ga. - 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Medical Inc. Pencan, Spinocan Spinal Needles and Spinal Introducer Needles:

Based on the provided 510(k) summary (K112515), the device in question is a medical needle, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The acceptance criteria and study focus on demonstrating substantial equivalence to predicate devices through performance testing against established international standards and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Reference)	Reported Device Performance
ISO 9626:1991/Amd. 1:2001(E): "Stainless steel needle tubing for the manufacture of medical devices."	"Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for needle tubing.)
ISO 7864:1993(E): "Sterile hypodermic needles for single use."	"Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for sterile hypodermic needles.)
ISO 594-1:1986: "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part1: General Requirements."	"Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for Luer taper fittings, confirming proper connection with other medical equipment.)
ISO 594-2:1998: "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings."	"Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for Luer lock fittings, ensuring secure connections.)
ISO 10993-1:2009: "Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process" (Biocompatibility)	"Biocompatibility testing... demonstrates that the materials used in the construction of the proposed needles are safe for their intended use." (Confirms the materials are biologically suitable for patient contact.)
Substantial Equivalence to Predicate Devices	The proposed Pencan and Spinocan needles are deemed "similar" to predicate devices (K932569, K820047, K011122) in intended use, needle cannula, tip design, and dimensions, with primary differences being hub geometry, non-solution contacting materials, and additional gauges/lengths. Compliance with performance standards further supports equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

This is not an AI/ML device study. The "testing" refers to physical and material performance evaluations against established standards, not a clinical trial with patient data. Therefore, concepts like "test set" or "data provenance" in the context of clinical data are not applicable here. The data provenance would be the internal testing laboratories of B. Braun Medical Inc. or contracted testing facilities that conducted the performance and biocompatibility tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for this type of medical device submission. Ground truth for physical device performance is established by objective measurements against engineering and material science standards (e.g., tensile strength, flow rate, biocompatibility assays), not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement. For a physical device demonstrating compliance with standards, the results are objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and therefore no MRMC study involving human readers with AI assistance was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. Its performance is inherent to its physical design and materials.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the international standards themselves (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ISO 10993-1). The device must meet the specified test methods and criteria outlined in these standards. For biocompatibility, the chemical and biological properties of the materials, as tested according to ISO 10993 guidelines, serve as the ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and does not involve a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device and does not involve a training set.

In summary, for K112515, the "study" demonstrating the device meets acceptance criteria consists of:

Performance testing against established international standards (ISO).
Biocompatibility testing in accordance with ISO 10993-1.
Comparison to predicate devices to demonstrate substantial equivalence based on similar design, materials, and intended use, and successful performance against the aforementioned standards.

The B. Braun Pencan and Spinocan Spinal Needles and Spinal Introducer Needles are traditional medical devices, and their regulatory pathway focuses on demonstrating safety and effectiveness through compliance with recognized standards and substantial equivalence to legally marketed predicate devices, rather than through AI/ML-specific validation studies.

Summary

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K112515

B. Braun Medical Inc. 510(k) Premarket Notification Pencan, Spinocan Spinal Needles and Spinal Introducer Needles December 16, 2011

DEC 2 2 2011

5. 510(k) SUMMARY

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500
	Contact: Lisa Giaquinto, Specialist, Regulatory AffairsPhone: (610) 596-2354Fax: (610) 266-4962E-mail: lisa.giaquinto@bbraun.com
DEVICE NAME:	Pencan Spinal Needles, Spinocan Spinal Needles, SpinaIntroducer Needles
COMMON ORUSUAL NAME:	Needle, Conduction, Anesthetic (W/Wo Introducer)

DEVICE CLASSIFICATION:

Class II, Product Code BSP, 21 CFR 868.5150

PREDICATE DEVICES: Pencil Point Spinal Needle, B. Braun Medical Inc., K932569, Class II, BSP, 868.5150. Spinocan Spinal Needle, B. Braun Medical Inc., K820047, Class II, BSP, 868.5150 Ballpen Spinal Needle, RUSCH INTL, K011122, Class II, BSP, 868.5150
DESCRIPTION: The B. Braun Pencan Spinal Needle consists of a polycarbonate hub bonded to a stainless steel cannula with pencil-point tip. The hub of the Pencan spinal needle incorporates a viewing window for visualization of cerebrospinal fluid. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 22 Ga. to 27 Ga. Needles that are 24 Ga .- 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.

The B. Braun Spinocan Spinal Needle consists of the same polycarbonate hub as the Pencan needles. The hub is bonded to a stainless steel cannula with Quincke bevel. The needles are provided with a stylet with color-coded hub that corresponds to the

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B. Braun Medical Inc. 510(k) Premarket Notification Pencan, Spinocan Spinal Needles and Spinal Introducer Needles December 16, 2011

needle gauge. The needles will be offered in gauges ranging from 18 Ga. to 27 Ga. Needles that are 25 Ga. - 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.

INTENDED USE:

SUBSTANTIAL EQUIVALENCE:

The proposed B. Braun Pencan spinal needles and spinal introducer needles are similar to the Pencan spinal needles and introducer needle included in cleared premarket notification # K932569. Both the proposed Pencan spinal needles and predicate needles incorporate the same needle cannula and pencil point tip design. The primary differences between the proposed Pencan spinal needles and spinal introducer needles when compared to the predicate devices are the geometric shape of the needle hubs, nonsolution contacting materials and additional needle gauges and lengths.

Similarly, the proposed Spinocan spinal needles are similar to the Spinocan spinal needles cleared under premarket notification # K820047. Both the proposed Spinocan needles and predicate device have the same intended use, and incorporate the same needle cannula, and Quincke tip design. The primary differences between the proposed Spinocan needles and the predicate Spinocan needles is the needle hub geometry, non-solution contacting materials and additional needle gauges and lengths.

The proposed Pencan and Spinocan spinal needles are also similar in intended use and needle dimensions to the BallPen Spinostar Spinal needles marketed by Teleflex Medical under premarket יירי

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B. Braun Medical Inc. 510(k) Premarket Notification Pencan; Spinocan Spinal Needles and Spinal Introducer Needles December 16, 2011

notification # K011122. The proposed needles and BallPen spinal needles are similar in needle and stylet design and may be used with a corresponding introducer needle.

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Performance Testing

The following performance standards have been utilized in the evaluation of the proposed Pencan and Spinocan spinal needles and spinal introducer needles:

ISO 9626:1991/Amd. 1:2001(E) "Stainless steel needle tubing for the manufacture of medical devices."

ISO 7864:1993(E) "Sterile hypodermic needles for single use."

ISO 594-1:1986, "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part1: General Requirements."

ISO 594-2:1998 "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings. "

Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use.

Biocompatibility

Biocompatibiltiy testing based on the nature and duration of patient contact outlined in ISO 10993-1:2009 "Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process" demonstrates that the materials used in the construction of the proposed needles are safe for their intended use.

Conclusion

Based on the indications for use and results of performance and biocompatibility testing, the proposed needles are considered similar to the predicate devices identified above, and are safe and effective for their intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an emblem that appears to be an abstract representation of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

Ms. Lisa Giaquinto Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K112515

Trade/Device Name: Pencan Spinal Needle, Spinocan Spinal Needle, Spinal Introducer Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Needle, Conduction, Anesthetic (W/Wo Introducer) Regulatory Class: II Product Code: BSP Dated: December 19, 2011 Received: December 21, 2011

Dear Ms. Giaquinto:

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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Page 2 - Ms. Giaquinto

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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B. Braun Medical Inc. 510(k) Premarket Notification Pencan, Spinocan Spinal Needles and Spinal Introducer Needles

4. INDICATIONS FOR USE STATEMENT

Page __ 1 of __ 1

510(k) Number (if known):

Device Names:

Pencan Spinal Needle, Spinocan Spinal Needle, Spinal Introducer Needle

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Achutkin

Division Sign-Off) Tivision of Anesthesiology, General Hospital . Tection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).