(81 days)
Not Found
No
The summary describes a mechanical safety mechanism for a needle and does not mention any computational or data-driven components indicative of AI/ML.
No
The device delivers an anesthetic and/or therapeutic agent, but it is not itself a therapeutic agent or device. It is a delivery mechanism, not a treatment.
No
The device is described as an active needle stick prevention device used for delivering anesthetic/therapeutic agents or facilitating epidural catheter placement. Its intended use is interventional/therapeutic, not diagnostic.
No
The device description clearly states it is a physical needle with a safety mechanism, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used by physicians to access the epidural space for delivering anesthetic/therapeutic agents or placing an epidural catheter. This is a direct intervention on the patient's body.
- Device Description: The description focuses on the physical characteristics of the needle and its safety mechanism.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly administer substances or place devices within the body. This device is a surgical/procedural tool.
N/A
Intended Use / Indications for Use
An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.
Product codes (comma separated list FDA assigned to the subject device)
73 BSP
Device Description
The Perifix® Safety Epidural Needle will be available in a 17 Gauge and 18 Gauge size and the usable length of the needle will be 3 ½ inches. The device consists of a safety device mechanism to reduce the risk of needlesticks.
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
Not Found
Intended User / Care Setting
Physicians
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)
Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the Perifix® Safety Epidural Needle.
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.
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for B. Braun, a German medical and pharmaceutical device company. The logo consists of the letter "B", a vertical line, and the word "BRAUN" in bold, sans-serif font. The logo is simple and recognizable, and it is often used on the company's products and marketing materials. The logo is in black and white.
JAN 2 5 2002
Summary of Safety and Effectiveness Information [510(k) Summary]
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2375
Contact: Sheri L. Musgnung, RA Manager |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Perifix® Safety Epidural Needle |
| COMMON OR USUAL
NAME : | Safety Epidural Cannula |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 868.5150: Anesthesia conduction needle and
868.5140: Anesthesia Conductin Kit . |
| PREDICATE DEVICE: | B. Braun Medical Inc. Perican Epidural Cannula, K813179
B. Braun Medical Inc. Perifix Set for Epidural Anesthesia Tuohy
Needle / Catheter, K813186
B. Braun Medical Inc. Introcan Safety IV Catheter, K982805. |
| DESCRIPTION: | The Perifix® Safety Epidural Needle will be available in a 17 Gauge
and 18 Gauge size and the usable length of the needle will be
3 ½ inches. The device consists of a safety device mechanism to
reduce the risk of needlesticks. |
| INTENDED USE: | An active needle stick prevention device used by physicians to
access the epidural space for the purpose of delivering an
anesthetic and/or therapeutic agent or to facilitate placement of
an epidural catheter. The needle can be used for single dose
administration or in conjunction with the epidural catheter for
continuous administration. |
| SUBSTANTIAL
EQUIVALENCE: | The Perifix® Safety Epidural Needle is identical in materials
and intended use to B. Braun Medical's premarket notification,
Perican Epidural Cannula, K813179 and B. Braun Medical's
premarket notification, Perifix Set for Epidural Anesthesia
Tuohy Needle/Catheter, K813186. The safety mechanism that is
utilized in this device has also been cleared in B. Braun
Medical's premarket notification, Introcan Safety IV Catheter,
K982805. Functional testing was performed to support that
there are no new issues of safety or effectiveness raised by the
Perifix® Safety Epidural Needle. |
1
Image /page/1/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 caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Ms. Sheri L. Musgnung B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109
Re: K013610
Perifix® Safety Epidural Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II (two) Product Code: 73 BSP Dated: October 31, 2001 Received: November 5, 2001
Dear Ms. Musgnung:
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. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Sheri L. Musgnung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc acrised that I Dr. break that your device complies with other requirements of the Act that I DIT has made a aond regulations administered by other Federal agencies. You must of any I cacal statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by bections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematics notification " 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 regulation (21 CFR Part 801 and If you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of Compinance at (301) 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ingulation cititived, "Niberansibilities under the Act may be obtained from the Other general information the mational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. D. Johnson, M.D.
am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
BIBR
2.0 Indications for Use Statement
Page __ 1_____________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: Perifix® Safety Epidural Needle
Indications For Use:
An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ ﮯ (Per 21 CFR 801.109) OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K013610
0000003