(107 days)
The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
The StarchMark Biopsy Site Marker is a sterile, disposable applicator containing 4 resorbable polysaccharide (starch) pellets and a polylactic/polyglycolic acid-based co-polymer (PLA/PGA) pellet with an embedded radiopaque wireform.
The provided text describes a 510(k) summary for the StarchMark Biopsy Site Marker. It details the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain specific acceptance criteria or the details of a study structured to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy, which would typically be found in performance studies for diagnostic devices.
Instead, the submission focuses on preclinical studies and biocompatibility testing to demonstrate safety and functional aspects under simulated use conditions and to meet ISO 10993-1 requirements. The "study" mentioned is primarily a comparison to a predicate device for substantial equivalence.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific quantitative thresholds (e.g., sensitivity, specificity, accuracy) are provided in the document for the StarchMark Biopsy Site Marker in terms of diagnostic performance. The document focuses on demonstrating substantial equivalence to an existing predicate device (K031938; Gel Mark III Biopsy Site Marker).
The "performance" is reported in terms of:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance as intended under simulated use conditions (in vitro) | In vitro laboratory studies demonstrated intended performance. |
| Biocompatibility (ISO 10993-1) | Biocompatibility testing performed and met ISO 10993-1 requirements. |
| Control of bleeding (in vivo) | Demonstrated superiority over the control group in cessation of bleeding time in a porcine study. |
| Substantial Equivalence to Predicate Device | Found substantially equivalent based on: • Same indications for use• Same intended use• Same intended treatment site• Same operating principle• Same technological characteristics• Same packaging• Same sterilization method |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For in vitro laboratory studies: Not specified.
- For biocompatibility testing: Not specified.
- For the porcine study: Not specified.
- Data Provenance: Not specified. The document does not mention the country of origin of data or whether studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies mentioned (in vitro, biocompatibility, porcine bleeding control) do not involve human expert interpretation for establishing a "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As the studies described do not involve human diagnostic interpretation for a test set, adjudication methods are not applicable here.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported.
- Effect Size of AI assistance: Not applicable, as this device is a biopsy site marker and not an AI-powered diagnostic tool. The document describes a medical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: This question is not applicable as the StarchMark Biopsy Site Marker is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic performance studies (e.g., against pathology for cancer detection) is not directly applicable to the reported studies.
- For in vitro studies: Performance "as intended" under simulated use implies comparison against pre-defined functional specifications.
- For biocompatibility: ISO 10993-1 standards serve as the "ground truth" or benchmark.
- For the porcine study: "Cessation of bleeding time" in the control group served as a comparative "ground truth" for evaluating superiority.
8. The sample size for the training set
This information is not applicable as the described studies are not for training an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as the described studies are not for training an algorithm.
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Kog 1085 リズ
AUG - 1 2008
5. 510(K) SUMMARY
| Date prepared | April 14, 2008 |
|---|---|
| Name | SenoRx, Inc.11 ColumbiaAliso Viejo, CA 92656T. 949.362.4800; F. 949.362.0300 |
| Contact person | Eben GordonVice President, RA/QASenoRx, Inc.T. 949.362.4800; F. 949.362.0300 |
| Device name | StarchMark |
| Common name | Biopsy site marker |
| Classification name | Implantable Clip |
| Classification regulation | 878.4300 NEU |
| Predicate devices | K031938; Gel Mark III Biopsy Site Marker; Clearance date: 9/5/2003 |
| Description | The StarchMark Biopsy Site Marker is a sterile, disposable applicatorcontaining 4 resorbable polysaccharide (starch) pellets and apolylactic/polyglycolic acid-based co-polymer (PLA/PGA) pellet with anembedded radiopaque wireform. |
| Indications for use | The StarchMark Biopsy Site Marker is intended to radiographically mark breasttissue during a percutaneous breast biopsy procedure. |
| Summary of substantialequivalence | Preclinical studies conducted included in vitro laboratory studies to demonstratethat the StarchMark Biopsy Site Marker performed as intended under simulateduse conditions. Biocompatibility testing was performed to demonstrate that thestarch pellet meet ISO 10993-1 requirements. In a porcine study designed toevaluate the control of bleeding, the StarchMark marker demonstratedsuperiority over the control group in the cessation of bleeding time.The StarchMark marker has the following similarities to the previously clearedpredicate device: |
| • Same indications for use; | |
| • Same intended use; | |
| • Same intended treatment site; | |
| • Same operating principle; | |
| • Same technological characteristics; |
- Same packaging; and
:
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- . Same sterilization method.
In summary, the StarchMark Biopsy Site Marker as described in this submission is substantially equivalent to the predicate device.
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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 forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2008
SenorRx, Inc. % Mr. Eben Gordon VP, Regulatory Affairs & Quality Assurance 11 Columbia Aliso Viejo, California 92656
Re: K081085
Trade/Device Name: StarchMark Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: July 29, 2008 Received: July 30, 2008
Dear Mr. Gordon:
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
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Page 2 - Mr. Eben Gordon
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.
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.
lf 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 Mulhearn
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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Indications for Use
510(k) Number (if known): K081085
Device Name: StarchMark Biopsy Site Marker
Indications for Use:
The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
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)
Mark N. Millerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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.