(139 days)
The Tumark® Professional is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure.
It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.
The Tumark® is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism. The introducer cannula which consists of stainless steel is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The handle is equipped with a slide-button which allows for a one handed placement. A safety catch system prevents the slide-button from inadvertently moving forward and therefore prevents a premature deployment of the marker.
This 510(k) summary does not contain information on acceptance criteria, device performance, or any studies conducted to prove the device meets specific acceptance criteria. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets those criteria based solely on the provided text. The document states that the Tumark Professional is "substantially equivalent" to predicate devices based on similar intended use, technology, design, and materials, suggesting that its performance is implicitly acceptable if the predicate devices' performance was.
Here's what I can extract from the provided text, related to your questions, but it's not the full scope of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Tumark Professional. It relies on the substantial equivalence argument.
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. No test set or data provenance is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not provided. No information on expert involvement for a test set.
4. Adjudication Method for the Test Set:
- Not provided. No information on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not provided. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance (which is not applicable here as this is a physical medical device, not an AI diagnostic tool).
6. Standalone Performance Study (Algorithm Only):
- Not provided. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Not provided. No studies with ground truth establishment are mentioned.
8. Sample Size for the Training Set:
- Not provided. No training set is mentioned as this device is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not provided. Not applicable as no training set is mentioned.
What is available in the document that might be related conceptually, though not directly answering your questions:
- The 510(k) summary focuses on establishing Substantial Equivalence to legally marketed predicate devices:
- ClipLoc Soft Tissue marker (K033447)
- UltraClip Tissue Marker (manufactured by Inrad Inc. - K number not provided but mentioned as a predicate)
- The basis for substantial equivalence is "same intended Use and the similarities in technology, design and materials."
- "Both the Tumark Professional and the predicate devices consist of the same primary components and the component materials of the proposed device and the predicate devices are substantially equivalent."
- "The minor technological differences between the proposed device and the predicate devices do not raise new questions of safety and effectiveness."
In essence, the device's "acceptance" is based on its similarity to already approved devices, implying that if the predicates are safe and effective, so too is the Tumark Professional. This type of submission (510(k)) often relies on comparisons to existing devices rather than new, extensive performance studies for novel acceptance criteria.
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KU73095 ソン
MAR 1 9 2008
510(k) SUMMARY
Tumark Professional
| Submitter: | Somatex Medical Technolgies GmbHRheinstrasse 7d14513 TeltowGermanyPhone: +49 3328 3076 13Fax: +49 3328 3076 99 |
|---|---|
| OfficialCorrespondent: | Susanne RaabRegulatory Affairs Consultant1480 Cambridge StreetCambridge, MA 02139Phone: 617 547 0628Fax: 617 520 2136e-mail: sbraab@comcast.net |
| Trade Name: | Tumark Professional |
| Common Name: | Tissue Site Marking System |
| Classification Name: | Radiographic Implantable Marker, 21 C.F.R. 878.4300 |
| Regulatory Class: | II |
| Product Code: | NEU |
| Device Description: | The Tumark® is a sterile, single use, preloaded tissue sitemarking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastichandheld applier with deployment mechanism. Theintroducer cannula which consists of stainless steel isdesigned with 1 cm depth marks, a beveled tip and anultrasound enhancement on the distal end. The handle isequipped with a slide-button which allows for a one handedplacement. A safety catch system prevents the slide-button |
| from inadvertently moving forward and therefore prevents apremature deployment of the marker. | |
| Intended Use: | The Tumark® Professional is intended to attach a marker tosoft tissue at the surgical site during an open or apercutaneous procedure. It is indicated for use toradiographically and radiologically mark the surgicallocation in breasts following an open or percutaneousprocedure. It is not indicated to be used with magneticresonance imaging (MRI) techniques. |
| SubstantialEquivalence: | The Tumark Professional is substantial equivalent to theClipLoc Soft Tissue marker (the "ClipLoc") manufacturedby MRI Devices Corporation (K033447) and the UltraClipTissue Marker (the "UltraClip") manufactured by Inrad Inc.The Tumark and each of its predicate devices are intended toattach a marker to soft tissue at the surgical site during anopen or a percutaneous procedure. All three devices areindicated for use to radiographically and radiologically markthe surgical location in breasts following an open orpercutaneous procedure. |
| In addition, both the Tumark Professional and the predicatedevices are similar in technology, design and material. Boththe Tumark Professional and the predicate devices consist ofthe same primary components and the component materialsof the proposed device and the predicate devices aresubstantially equivalent. | |
| Based on the same intended Use and the similarities intechnolgy, design and materials the Tumark Professional issubstantially equivalent to its predicate devices. The minortechnological differences between the proposed device andthe predicate devices do not raise new questions of safetyand effectiveness. | |
| Date Prepared: | February 19, 2008 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2008
Somatex Medical Technologies GmbH % Ms. Susanne Raab 1480 Cambridge Street Cambridge, Massachusetts 02139
Re: K073095
Trade/Device Name: Tumark Professional Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 23, 2008 Received: February 27, 2008
Dear Ms. Raab:
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.
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Susanne Raab
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K073095
Device Name: Tumark Professional
Indications for Use:
The Tumark® Professional is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure.
It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.
X 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sanita
Vision Sign-Co.
ision of General, Kestorative and Neurological Devices
510(k) Mr.
Page 1 of 1
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.