(125 days)
The Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible uneler ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The Biopsy Sciences HydroMark Biospy Site Markers are made of The Bropsy Deleal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark also contains a titanium coil that provides permanent visibility under xray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile, The Hydroman's Stor that is compatible with the J&J Ethicon disposaore applicator tome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HydroMark Biopsy Site Marker:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria with reported performance metrics. However, based on the "Intended Use" and "Technological Characteristics" sections, we can infer the implied acceptance criteria and the claims made about the device's performance.
| Criterion | Reported Device Performance/Claimed Characteristic |
|---|---|
| Mark tissue during a percutaneous breast biopsy | The hydrogel component expands on fluid contact to fill the void created during the biopsy, leaving the HydroMark at the exact location of biopsy. Non-clinical and animal test results demonstrate the HydroMark accurately marks the biopsy site. |
| Visible under ultrasound for at least 6 weeks | The HydroMark is highly visible under ultrasound imaging. Because the hydrogel is hydrophilic, it is clearly distinct from normal breast structure under ultrasound imaging. |
| Permanently visible by X-ray | The HydroMark also contains a titanium coil that provides permanent visibility under x-ray. The hydrogel material degrades via hydrolysis over time leaving the internal Titanium coil which provides permanent visibility under x-ray. The HydroMark assures permanent visibility under x-ray. |
| Permanently visible by MRI | The HydroMark is visible under magnetic resonance imaging. The HydroMark also contains a titanium coil that provides permanent visibility under MRI. The HydroMark assures permanent visibility under MRI with minimal artifacts. |
| Does not migrate | Non-clinical testing included evidence that the site marker does not migrate over time. The HydroMark does not migrate. |
| Biocompatible | Non-clinical testing included biocompatibility of the components. |
| Delivery system compatible with Mammotome probe | Non-clinical testing included validation that delivery system is compatible with the commercially available Mammotome biopsy probe. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in the context of human clinical trials for establishing performance metrics against acceptance criteria. The testing described is primarily non-clinical and animal testing.
- Test Set Sample Size: Not specified for human clinical data. The studies mentioned are non-clinical and animal studies.
- Data Provenance: The document does not specify the country of origin for the animal studies or any human clinical data that might have been used in a "test set." It can be inferred that these studies were likely conducted in the US, given the submission to the FDA. The studies are prospective in nature, as they involve testing the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the primary evidence cited is non-clinical and animal testing, there is no mention of experts establishing a ground truth for a human test set. The evaluation of visibility, migration, and accurate marking in animal studies would have likely been performed by researchers and veterinarians, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
As there is no mention of a human clinical test set requiring expert ground truth, no adjudication method (like 2+1 or 3+1) is described. The evaluation in non-clinical and animal studies would follow experimental protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned. This document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical and animal performance data, rather than comparative effectiveness studies with human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone study (algorithm only) was not performed. The HydroMark Biopsy Site Marker is a physical medical device, not an AI algorithm. Therefore, the concept of "algorithm only" performance does not apply. The performance is intrinsically linked to the physical properties of the marker and its interaction with biological tissue and imaging modalities.
7. Type of Ground Truth Used
The ground truth for the claims made is established through:
- Direct Observation/Measurement in Non-Clinical Testing: For biocompatibility, delivery system compatibility, and migration.
- Imaging Observations in Animal Studies: For accurate marking, visibility under ultrasound, X-ray, and MRI, and assessment of migration.
- Material Science/Chemical Properties: For the degradation of the hydrogel via hydrolysis and the permanent visibility of the titanium coil.
8. Sample Size for the Training Set
This product is a physical medical device, not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of AI does not apply.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this device. The development and verification of the device's properties would involve standard engineering, material science, and biological testing methodologies rather than AI-specific training paradigms.
{0}------------------------------------------------
Ko60769
Image /page/0/Picture/1 description: The image shows the word "psy" in a serif font, with the letters "p", "s", and "y" clearly visible. To the left of the word "psy" is a black square. Below the black square and the word "psy" is the word "Sciences" in a serif font.
JUL 25 2006
510(K) SUMMARY (21 CFR 807.92)
HYDROMARK BIOPSY SITE MARKER
Biopsy Sciences, Inc. 510(k) Owner: 3433 East Fort Lowell Road, Suite 103 Tucson AZ 85716 Tel: 520-325-9086 Fax: 520-881-4686
- Sharon Rockwell Contact Person: Tel: 714-695-9269 E-mail: srockwell@writeme.com
March, 2006 Date Prepared:
HydroMark Biopsy Site Marker Trade Name:
Biopsy site marker Common Name:
Classification Name: Implantable staple per 21 CFR 878.4750, FZP
Biopsy Sciences Bio-Mark Biopsy Site Marker, K023694 Predicate Devices: Diopsy Sciences Bio-Seal Lung Biopsy Site Marker, K041331 InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor, K053518 J&J MicroMark Biopsy Clip, K970817
The Biopsy Sciences HydroMark Biospy Site Markers are made of Device Description: The Bropsy Deleal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark also contains a titanium coil that provides permanent visibility under xray and MRI.
The HydroMark Site Marker is provided pre-loaded in a sterile, The Hydroman's Stor that is compatible with the J&J Ethicon disposaore applicator tome probe. The HydroMark is deployed
{1}------------------------------------------------
by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.
Intended Use: The Biopsy Sciences, Inc. 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 indications are identical to those of the predicate device, the Biopsy Sciences Bio-Mark Biopsy Site Marker.
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 Titanium coil which provides permanent visibility under x-ray and MRI.
Non-Clinical Performance Data:
Non-clinical testing included biocompatibility of the components. validation that delivery system is compatible with the commercially available Mammotome biopsy probe, and evidence that the site marker does not migrate over time. The HydroMark is highly visible under ultrasound imaging, does not migrate, and assures permanent visibility under x-ray and MRI with minimal artifacts. The device performs as intended and has the identical intended use as predicate devices previously cleared under 510(k)s.
- Conclusions: The non-clinical and animal test results demonstrate the HydroMark accurately marks the biopsy site. The testing supports a determination of substantial equivalence to products and technologies previously cleared by FDA.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle-like symbol with three curved lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 25 2006
Ms. Sharon Rockwell Vice-President, Regulatory and Clinical Affairs Biopsv Sciences, LLC 3433 East Fort Lowell Road TUCSON AZ 85718
Re: K060769
Trade/Device Name: HydroMark Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: June 14, 2006 Received: June 19, 2006
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The text is written in a decorative, cursive font.
{3}------------------------------------------------
Page 2 -
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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K060769
Device Name: HydroMark 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 uneler 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page ___ of ___
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
§ 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.