(81 days)
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.
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.
The provided document is a 510(k) summary for the B. Braun Perifix® Safety Epidural Needle. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study with acceptance criteria and a detailed performance evaluation of a novel algorithm or AI system.
Therefore, the requested information points (1-9) which are typical for studies evaluating novel medical devices, especially those incorporating AI or complex algorithms, cannot be fully extracted or are not directly applicable from this 510(k) summary for the following reasons:
- This is not an AI/algorithm-driven device: The Perifix® Safety Epidural Needle is a mechanical device designed to prevent needlesticks. It does not involve any algorithm, AI, or software that would require performance metrics like sensitivity, specificity, or AUC against a ground truth.
- Focus on Substantial Equivalence: The 510(k) pathway "demonstrates that the new device is substantially equivalent to a legally marketed predicate device. This means that the new device has the same intended use as the predicate device and has the same technological characteristics as the predicate device." (FDA website). The "study" here refers to demonstrating this equivalence through functional testing and comparison, not a clinical trial with specific performance metrics against a defined ground truth in the way one would evaluate an AI diagnostic tool.
However, I can provide the available information, interpreting "acceptance criteria" as the basis for claiming substantial equivalence and "reported device performance" as the evidence presented for that claim:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance and Evidence Presented |
|---|---|
| Intended Use: Device must have the same intended use as predicate device(s). | Met: "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." This is stated as identical to B. Braun Medical's Perican Epidural Cannula (K813179) and Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter (K813186). |
| Materials: Device must be identical in materials to predicate device(s). | Met: "The Perifix® Safety Epidural Needle is identical in materials [...] 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." |
| Technological Characteristics: Device must have similar technological characteristics, or differences must not raise new questions of safety or effectiveness. | Met: The safety mechanism utilized in this device has been previously cleared in B. Braun Medical's 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." |
| Performance: Must demonstrate that any differences in technological characteristics do not raise new questions of safety or effectiveness. | Met: "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the Perifix® Safety Epidural Needle." (Specifics of this functional testing are not detailed in this summary, but would have been part of the full 510(k) submission). |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context would be the functional tests performed on the device itself. The document does not specify a numerical sample size for these tests (e.g., how many needles were tested or how many times the safety mechanism was activated). It also doesn't involve patient data or data provenance in the sense of country of origin or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. A "ground truth" derived from expert consensus is not relevant for this type of mechanical device. The "ground truth" for functional testing would be whether the device performed according to its engineering specifications and design, as verified by internal testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation), not functional testing of mechanical devices.
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 a mechanical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of typical AI/diagnostic studies. For this device, the "ground truth" for the functional testing would relate to engineering specifications, mechanical reliability, and safety mechanism activation under defined test conditions, rather than clinical outcomes or expert labels.
8. The sample size for the training set: Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable. No training set is involved.
In summary, the document states that the Perifix® Safety Epidural Needle achieved acceptance criteria by demonstrating substantial equivalence to existing predicate devices (Perican Epidural Cannula, K813179; Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter, K813186; and Introcan Safety IV Catheter, K982805 for the safety mechanism). This was achieved by confirming identical materials and intended use, and by performing functional testing to ensure the safety mechanism did not raise any new safety or effectiveness concerns compared to the already cleared predicate devices.
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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 BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2375Contact: Sheri L. Musgnung, RA Manager |
|---|---|
| DEVICE NAME: | Perifix® Safety Epidural Needle |
| COMMON OR USUALNAME : | Safety Epidural Cannula |
| DEVICECLASSIFICATION: | Class II, 21 CFR 868.5150: Anesthesia conduction needle and868.5140: Anesthesia Conductin Kit . |
| PREDICATE DEVICE: | B. Braun Medical Inc. Perican Epidural Cannula, K813179B. Braun Medical Inc. Perifix Set for Epidural Anesthesia TuohyNeedle / Catheter, K813186B. Braun Medical Inc. Introcan Safety IV Catheter, K982805. |
| DESCRIPTION: | The Perifix® Safety Epidural Needle will be available in a 17 Gaugeand 18 Gauge size and the usable length of the needle will be3 ½ inches. The device consists of a safety device mechanism toreduce the risk of needlesticks. |
| INTENDED USE: | An active needle stick prevention device used by physicians toaccess the epidural space for the purpose of delivering ananesthetic and/or therapeutic agent or to facilitate placement ofan epidural catheter. The needle can be used for single doseadministration or in conjunction with the epidural catheter forcontinuous administration. |
| SUBSTANTIALEQUIVALENCE: | The Perifix® Safety Epidural Needle is identical in materialsand intended use to B. Braun Medical's premarket notification,Perican Epidural Cannula, K813179 and B. Braun Medical'spremarket notification, Perifix Set for Epidural AnesthesiaTuohy Needle/Catheter, K813186. The safety mechanism that isutilized in this device has also been cleared in B. BraunMedical's premarket notification, Introcan Safety IV Catheter,K982805. Functional testing was performed to support thatthere are no new issues of safety or effectiveness raised by thePerifix® Safety Epidural Needle. |
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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.
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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
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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
§ 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).