(34 days)
The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue.
The Prostate Tissue Marker consists of a pure gold marker placed inside a 17 Ga disposable beveled needle applicator. Also contained in the needle are 2 resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks.
This is an FDA 510(k) premarket notification for the SenoRx Prostate Tissue Marker. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with acceptance criteria.
Therefore, many of the requested categories for a comprehensive performance study (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included or required in a 510(k) summary focused on substantial equivalence.
Based on the provided document, here's the information that can be extracted or deduced:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission focuses on demonstrating that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
The "performance" described is largely based on the equivalence to predicate devices:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (as described in the submission) |
|---|---|
| Intended Use: Radiographic marking of prostate tissue. | The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue. It is "identical" to the Gel Mark UltraCor Biopsy Site Marker (K080698) except for the intended use being prostate tissue rather than breast. The Fiducial Marker (CIVCO, K071614) is also used to mark soft body tissues, including the prostate. |
| Technological Characteristics: | Consists of a pure gold marker inside a 17 Ga disposable beveled needle applicator. Contains 2 resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG) plug. The gold marker is intended for long-term radiographic marking. Pellets visible via ultrasound for ~4 weeks, essentially resorbed in ~12 weeks. The "principle of operation, method of use, technological characteristics, and basic design are the same for the SenoRx device and similar to the CIVCO device." The CIVCO device also uses pure gold with approximately the same mass. |
| Safety and Effectiveness: No new questions raised. | The submission implicitly asserts that because the device is substantially equivalent to legally marketed predicate devices, it is safe and effective for its stated indications for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The 510(k) summary does not detail a clinical test set or study with specific sample sizes. Substantial equivalence is demonstrated through comparison to predicates, material characterization, and potentially bench testing, not typically through a clinical performance study with a 'test set' as defined for AI/software.
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)
Not applicable. No ground truth establishment for a clinical test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and related adjudication method are 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 is a tissue marker device, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a tissue marker device, not an AI or software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described in the context of a performance study in this 510(k) summary. The "ground truth" for the device's function is its physical presence and radiopacity as observed in imaging, and its biocompatibility, which would have been assessed through preclinical testing (not detailed in this summary).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI algorithm.
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SENORx
K081170 page 1
7.
MAY 2 8 2008
and the control control control control controlled in the controlled
| 7. 510(K) SUMMARY | MAY 28 2008 | |
|---|---|---|
| Date prepared | April 23, 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 | Prostate Tissue Marker | |
| Common name | Tissue marker | |
| Classification name | Implantable Clip | |
| Classification regulation | 878.4300 NEU | |
| Predicate device | Gel Mark UltraCor Biopsy Site Marker, K080698, Clearance date: 3/31/2008; NEUFiducial Markers, K071614, Clearance date: 9/11/2007; IYE | |
| Description | The Prostate Tissue Marker consists of a pure gold marker placed inside a 17 Gadisposable beveled needle applicator. Also contained in the needle are 2 resorbablepolylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG)plug in the needle bevel. The gold marker is intended for long-term radiographicmarking of the tissue site. The pellets are visible via ultrasound for approximately 4weeks and are essentially resorbed in approximately 12 weeks. | |
| Indications for use | The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue. | |
| Summary of substantialequivalence | The Prostate Tissue Marker is identical to the Gel Mark UltraCor Biopsy Site Marker(SenoRx, K080698) except for the intended use being prostate tissue rather than anothersoft tissue, breast. The Fiducial Marker (CIVCO, K071614) is also used to mark softbody tissues, including the prostate for the treatment of tumors. The CIVCO FiducialMarker itself is also pure gold with approximately the same mass as the proposeddevice. The principle of operation, method of use, technological characteristics, andbasic design are the same for the SenoRx device and similar to the CIVCO device. Theindication for use, intended use, and treatment site for the Prostate Tissue Marker is asubset of that for the CIVCO device and represents a different soft tissue target for theSenoRx device. |
and the comments of the comments of the comments of the comments of
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SenoRx, Inc. % Mr. Eben Gordon VP, RA/QA 11 Columbia Aliso Viejo, California 92656
Re: K081170
Trade/Device Name: Prostate Tissue Marker Regulation Number: 21 CFR 878.4300 Device Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: April 23, 2008 Received: April 29, 2008
Dear Mr. Hawkins:
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 (OS) 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 - Mr. Eben Gordon
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 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. Milliman
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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6. INDICATIONS FOR USE
510(k) Number (if known): KOG | | 70
Device Name: _________________________________________________________________________________________________________________________________________________________________ Prostate Tissue Marker
Indications for Use:
The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue.
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)
Neil Rp Oyl for rxn
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081170
11
§ 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.