(131 days)
Stimuplex® Pen is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, lor looding openhold peripieral hervey. Ban invesive device non invasive device.
The Stimuplex® Pen is an electrode for cutaneous stimulation which, when connected to the Stimuplex® HNS 11 or HNS 12 nerve stimulator and placed on the skin, it conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia whitin the distribution area of a nerve. The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve.
The provided text is a 510(k) summary for the Stimuplex® Pen, a device for cutaneous electrical nerve stimulation. It does not include detailed studies with specific acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness.
The document primarily focuses on establishing substantial equivalence to a predicate device (Nerve Mapping Probe for NeuroTrace III Nerve Stimulator K023342) based on general technological characteristics, intended use, and safety. There is no mention of a clinical study designed to quantitatively assess the device's performance against predefined acceptance criteria.
Therefore, I cannot fulfill all parts of your request based on the provided text. However, I can extract what is available regarding the device's "performance" and the general approach to demonstrating its "safety and effectiveness."
Here's a breakdown of what can be inferred or directly stated from the text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document mentions "required release specifications" and "product design specifications" for manufacturing and quality control. However, it does not provide quantitative acceptance criteria (e.g., a specific accuracy or sensitivity threshold for nerve localization). The general acceptance criterion implied is that the device functions as intended to conduct electrical impulses for cutaneous nerve stimulation.
- Reported Device Performance:
- Functionality: "It conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia within the distribution area of a nerve."
- Mechanism: "The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve."
- Safety & Effectiveness (in comparison to predicate): "The small power density difference doesn't affect safety and effectiveness for the intended use."
2. Sample size used for the test set and the data provenance:
- The document does not report on a specific test set or clinical study with a defined sample size for evaluating the device's ability to locate nerves. Instead, it refers to manufacturing and quality control testing.
- Data Provenance: Not applicable, as no clinical performance data is presented. The device manufacturer is Stockert GmbH, based in Freiburg, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical study involving expert ground truth establishment for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No clinical study involving a test set or adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document does not describe a multi-reader multi-case comparative effectiveness study. Its equivalence claim is based on technological characteristics and intended use compared to a predicate device, not on a human-in-the-loop performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to an extent, but not in the context of an "algorithm." The Stimuplex® Pen is a physical electrode device, not an AI algorithm. The closest equivalent to "standalone" performance testing mentioned is the "physical testing" and "visual examination" conducted as part of the manufacturing process to ensure the device meets "product design specifications" and "required release specifications." These tests are performed on the device itself.
7. The type of ground truth used:
- Manufacturing Specifications / Functional Output: For the manufacturing and quality control tests mentioned, the "ground truth" would be whether the device physically conforms to its design specifications (e.g., dimensions, material properties) and functionally produces the expected electrical output as defined by the associated nerve stimulators (Stimuplex® HNS 11/12).
- Not applicable for clinical performance evaluation as described in the request (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set:
- Not applicable. The Stimuplex® Pen is a hardware device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model is involved.
Summary of Device Acceptance and Study (based on provided text):
The Stimuplex® Pen's acceptance for marketing is based on demonstrating substantial equivalence to a previously legally marketed predicate device (Nerve Mapping Probe for NeuroTrace III Nerve Stimulator K023342) under the 510(k) pathway.
The "study" or evidence to prove the device meets acceptance criteria primarily involved:
- Comparison of Indicational Use: Showing that the Stimuplex® Pen has the same intended use as the predicate device (location of superficial peripheral nerves).
- Comparison of Technological Characteristics: Demonstrating that the fundamental technology (cutaneous electrical stimulation) and materials are equivalent. The differences (nerve stimulation parameters of the associated stimulators and tip diameter) were deemed not to affect safety and effectiveness.
- Manufacturing and Quality Control Testing: The document states, "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release includes, but is not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by quality control test procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." This indicates that individual units are tested against engineering and quality standards, but it's not a clinical performance study.
In essence, the "acceptance criteria" presented in this document are those for establishing substantial equivalence to a predicate device, supported by internal manufacturing quality controls, rather than a clinical performance study against specific objective performance metrics.
{0}------------------------------------------------
Annex II
12 2 2
Image /page/0/Picture/3 description: The image shows the logo for Stockert GmbH. The logo features a black and white crest on the left side, with a helmet and feathers on top. To the right of the crest is the text "Stockert GmbH" in a simple, sans-serif font, with a line underneath the text.
510(k) Summary
November 9, 2006
Bötzinger Straße 72 79111 Freiburg phone: ++49-761-20716-0 Fax: ++49-761-20716-20 eMail: info@stockert.de http://www.stockert.de
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Contact: Dominika Schuler, Management Representative
Trade Name: Stimuplex® Pen
Common Name: Device for cutaneous electrical nerve stimulation
Classification Name:
Neurological Devices, Class II, GXY Cutaneous electrode 21 CFR 882.1320
Predicate Device: Nerve Mapping Probe (accessory only) for NeuroTrace III Nerve Stimulator K023342
Superficial nerves can be stimulated electrically through the skin by means of a weak current. Cutaneous electrical nerve stimulation (CENS) represents a decisive advance in the location of superficial nerve structures: it enables the cutaneous projection of any superficial nerve to be determined and the point of needle entry to be optimized in order to more easily perform peripheral nerve block in adults and children.
The Stimuplex® Pen is an electrode for cutaneous stimulation which, when connected to the Stimuplex® HNS 11 or HNS 12 nerve stimulator and placed on the skin, it conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia whitin the distribution area of a nerve. The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve.
{1}------------------------------------------------
Stimuplex® Pen is intended to be used only with B.Braun's nerve stimulators: Stimuplex® HNS 11 (510k no. K003983) and/or Stimuplex® HNS 12 (510k no. K052313).
The configuration of the electrode connection is realized with a 1 pin plug safety connection system, which ensures correct polarity of the electrode to the Stimuplex® HNS 11 or HNS 12 nerve stimulator. The nerve stimulator generates neqative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. It displays the actual stimulation current so that the proper current flow can be checked.
The intended use is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, local/regional analgesia and neurology. Stimuplex® Pen is a prescription use only device, the patient is not the operator. It can be used on adult, pediatric, and/or infant population
The general technological characteristics of the Stimuplex® Pen are generally equivalent in materials, form and intended use to the Nerve Mapping Probe (accessory only) for the NeuroTrace III peripheral nerve stimulator. Differences between the Stimuplex® HNS 12 and the predicate device consist only in the nerve stimulation parameters of the nerve stimulators and the diameter of the tip, The small power density difference doesn't affect safety and effectiveness for the intended use.
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release includes, but is not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by quality control test procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.
sianed:
Dominika Schuler, Management Representative
Stockert GmbH
te: 2006-11-09
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dominika Schuler Management Representative Stockert GmbH Boetzinger Strasse 72 Freiburg, B-W, GERMANY, D-79111
NOV 2 1 2006
Re: K061983
Trade/Device Name: Stimuplex Pen Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: November 9, 2006 Received: November 13, 2006
Dear Ms. Schuler:
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.
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.
{3}------------------------------------------------
Page 2 – Ms. Mr. Schuler
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ovei Sullom for
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K061983
Device Name: Stimuplex Pen
Indications for Use:
Stimuplex® Pen is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, lor looding openhold peripieral hervey.
Ban invesive device non invasive device.
Intended patient population: for adult, pediatric and/or infant use.
Stimuplex® Pen is intended to be used only with B.Braun's nerve stimulators: Stimuplex® HNS 11 (510k no. K003983) and/or Stimuplex® HNS 12 (510k no. K05213). It can be used wherever peripheral anesthesia is normally applied (i.e. physician's office on hospital).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cuns Sulion
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).