(8 days)
The Biopsy Sciences LLC., HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The Biopsy Sciences HydroMark Breast Biopsy Site Markers are made of desiccated hydrogel embedded with either a stainless steel or titanium coil. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark Site Marker is currently provided pre-loaded in a sterile, disposable, flexible plastic syringe-like applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. Two modified applicators have been developed which are both 15 gauge stainless steel syringe-like applicators. One has cm markings and a beveled tip to aid in needle placement by direct puncture, or to fit inside a 13 gauge or larger coaxial needle. The distal tip of the applicator is etched to enhance its visibility under ultrasound guidance. An additional stainless steel applicator has been developed to be compatible with the Suros 12 gauge biopsy system. The hydrogel portion of the HydroMark Breast Biopsy Site Marker has a dimensional change to accommodate the 15 gauge applicators, which by design create smaller cavities. The titanium and stainless steel coils embedded in the hydrogel are identical to the original device.
The provided text describes modifications to an existing device (HydroMark Breast Biopsy Site Marker) and its substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new device.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in the provided document. The document focuses on regulatory approval (510(k)) based on modifications to an already approved device and its substantial equivalence to predicate devices.
However, I can extract the stated Intended Use which can be interpreted as the functional performance expected from the device, and the general conclusion regarding meeting design criteria.
Here's a breakdown of what can be inferred or is missing, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, it defines the intended use which implies the performance expectations. The "reported device performance" is essentially the claim that the device, with modifications, still meets these intended uses.
| Acceptance Criterion (Inferred from Intended Use) | Reported Device Performance (Claimed) |
|---|---|
| Intended to mark tissue during a percutaneous breast biopsy procedure | The HydroMark is clearly stated as "intended to mark tissue during a percutaneous breast biopsy procedure." |
| Be visible under ultrasound for at least 6 weeks | The HydroMark is stated as "be visible under ultrasound for at least 6 weeks." The hydrogel component is described as "clearly distinct from normal breast structure under ultrasound imaging." |
| Be permanently visible by x-ray and MRI | The HydroMark is stated as "be permanently visible by x-ray and MRI." The metallic coil provides "permanent visibility under x-ray and MRI." |
| Compatibility with specific applicators (modified) | Risk analysis identified tests for compatibility; these tests "were conducted and established that the HydroMark Breast Biopsy Site Markers in their modified applicators meet the design input criteria." |
| Compatibility of applicators with coaxial needles and Suros biopsy device | Risk analysis identified tests for compatibility; these tests "were conducted and established that the HydroMark Breast Biopsy Site Markers in their modified applicators meet the design input criteria." |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document describes a 510(k) submission for device modifications based on non-clinical performance data (bench testing related to compatibility) and substantial equivalence to predicate devices. It does not mention a clinical test set with human subjects to evaluate imaging visibility in a patient population. The data provenance is internal testing by Biopsy Sciences, Inc. for design verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No clinical test set with a need for expert-established ground truth is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set requiring adjudication is described.
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 document pertains to a physical medical device (biopsy marker), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device (biopsy marker), not an AI algorithm. Therefore, no standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided for clinical performance. For the non-clinical performance data (compatibility), the ground truth would be established by engineering specifications and successful function during testing.
8. The sample size for the training set
Not applicable/Not provided. This document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable/Not provided. This document does not describe the development or training of an AI algorithm.
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Biopsy
Sciences
K090501
page 1 of 3
MAR - 5 2009
SPECIAL 510(K) SUMMARY (21 CFR 807.92)
HYDROMARK BIOPSY SITE MARKER
510(k) Owner:
Biopsy Sciences, Inc. 4900 Creekside Drive, Suite C Clearwater, FL 33760 Tel: 727-290-9825 Fax: 727-290-9828
- Contact Person: Sharon Rockwell Tel: 714-695-9269 E-mail: srockwell@writeme.com
- Date Prepared: February, 2009
Trade Name: HydroMark Breast Biopsy Site Marker
- Common Name: Biopsy site marker
Classification Name: Implantable clip per 21 CFR 878.4300, NEU
Predicate Devices: Biopsy Sciences HydroMark Breast Biopsy Site Marker, K060769 and K083006 3 12 2018
Device Description: The Biopsy Sciences HydroMark Breast Biopsy Site Markers are made of desiccated hydrogel embedded with either a stainless steel or titanium coil. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis.
The HydroMark Site Marker is currently provided pre-loaded in a sterile, disposable, flexible plastic syringe-like applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. Two modified applicators have been developed which are both 15 gauge stainless steel syringe-like applicators. One has cm markings and a beveled tip to aid in needle placement by direct puncture, or to fit inside a 13 gauge or larger coaxial needle. The distal tip of the applicator is etched to enhance its visibility under ultrasound guidance. An additional stainless steel applicator has
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K 0 9 0 501
Page 2 of 3
been developed to be compatible with the Suros 12 gauge biopsy The hydrogel portion of the HydroMark Breast Biopsy system. Site Marker has a dimensional change to accommodate the 15 gauge applicators, which by design create smaller cavities. The titanium and stainless steel coils embedded in the hydrogel are identical to the original device.
Intended Use: The Biopsy Sciences, Inc. HydroMark Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The indications for use are identical to those of the predicate device, the Biopsy Sciences HydroMark Breast Biopsy Site Marker provided in an applicator for the Mammotome device.
Technological Characteristics:
Non-Clinical Performance Data: The HydroMark Breast Biopsy Site Markers, regardless of the applicators in which they are provided, have the same indications for use, principles of operation, materials and technological characteristics. The hydrogel component expands on fluid contact to fill the void created during the biopsy, leaving the HydroMark at the exact location of biopsy. Because the hydrogel is hydrophilic. it is clearly distinct from normal breast structure under ultrasound imaging. The hydrogel material degrades via hydrolysis over time leaving the internal metallic coil which provides permanent visibility under x-ray and MRI.
The only modifications from the predicate device are: 1) a change from the plastic syringe-like applicator to a stainless steel syringelike applicator with etched depth markings, an echogenic distal end for ultrasound visualization, and a ground tip for direct placement or placement through a 13 gauge coaxial needle, 2) a longer version of the stainless steel syringe-type applicator with a blunt tip that will accommodate the Suros ATECTM 12 STX gauge biopsy device, and 3) a change in the outer diameter of the HydroMark hydrogel component to accommodate the 15 gauge applicator, which by design produce smaller biopsy cavities.
Risk analysis relevant to the design modifications identified tests related to the compatibility of the HydroMark Site Markers with the applicators, and the compatibility of the applicators with coaxial needles and the Suros biopsy device. These tests, in addition to the applicable design verification and validation tests performed on the original device, were conducted and established
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K090501
Page 3 of 3
that the HydroMark Breast Biopsy Site Markers in their modified applicators meet the design input criteria.
Conclusions:
The HydroMark Breast Biopsy Site Markers supplied pre-loaded in a stainless steel applicator for insertion directly or through a coaxial needle, and supplied pre-loaded in a stainless steel applicator compatible with the Suros ATECTM 12 STX gauge biopsy device have the same indications for use, and are similar in design, functionality, and technological characteristics as the device to support a a substantially equivalent predicate determination. The modifications identified are minor in nature and do not raise any new issues of safety or efficacy.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2009
Biopsy Sciences, LLC % Ms. Sharon Rockwell Regulatory Affairs 5582 Chalon Road Yorba Linda, California 92886
Re: K090501
Trade/Device Name: Biopsy Sciences HydroMark Breast Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 10, 2009 Received: February 25, 2009
Dear Ms. Rockwell:
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. Sharon Rockwell
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 vours,
for fi, m.D., for
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 STATEMENT
510(k) Number (if known):
Device Name: Biopsy Sciences HydroMark Breast Biopsy Site Marker
Indications for Use:
The Biopsy Sciences LLC., HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
Prescription Use X (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)
Daniel Kroneberger 3/4/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Page 1 of
§ 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.