(83 days)
The Single Step™ Biopsy Device System is intended for breast lesion localization and diagnostic tissue sampling for histological examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Single Step™ Biopsy Device is an electrosurgical cutting instrument which uses radio frequency (RF) energy to localize a breast lesion and cut a sample of breast tissue for diagnostic biopsy.
This 510(k) premarket notification for the SenoRx Single Step™ Biopsy Device System does not contain the detailed study information required to answer the prompt in full.
The document is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an indications for use statement. While it describes the device and its intended use, it does not include the results of specific performance studies against acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes and data provenance, details on experts or ground truth establishment, or any information regarding MRMC studies or standalone algorithm performance.
Here's what can be inferred from the provided text:
- Acceptance Criteria/Study: Not explicitly stated in the provided document. The 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices, rather than requiring new clinical trials that establish acceptance criteria and prove performance against them in the same way a PMA would.
- Device Performance: The document states that "The intended use, design, construction, materials and technology are comparable to the predicate devices." This implies that its performance is expected to be similar to legally marketed devices, but no specific performance metrics or acceptance criteria are provided.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: None of this information is available in the provided text. The 510(k) submission process typically focuses on demonstrating equivalence through non-clinical testing (e.g., bench testing, material compatibility) and comparison to predicate device characteristics, rather than extensive clinical efficacy studies with ground truth establishment in the way described in the prompt.
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SenoRx Inc.
Premarket Notification
Single Step™ Biopsy Device System
AUG 1 4 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
KO21707 1/2
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
SUBMITTER INFORMATION 1.
| a. Company Name: | SenoRx Inc. |
|---|---|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone:Facsimile: | (949) 362-4800(949) 362-3519 |
| d. Contact Person: | Amy BouclyDirector, Regulatory Affairsand Quality Assurance |
e. Date Summary Prepared: May 22, 2002
1. DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | Single Step™ Biopsy DeviceSingle Step™ Surgical HandleSingle Step™ DriverSingle Step™ Holder |
|---|---|
| ---------------------------- | ---------------------------------------------------------------------------------------------------------- |
b. Classification Name: Electrosurgical Accessory, 878.4400
3. IDENTIFICATION OF PREDICATE DEVICES
| Anchor Guide™Localization and FixationDevice | SenoRx Inc. (K012023) |
|---|---|
| Shape Select™Electrosurgical Scalpel | SenoRx Inc. (K012799) |
| SenoCor™ Biopsy DeviceSystem | SenoRx Inc. (K013641) |
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K021707 2/2
SenoRx Inc. Premarket Notification Single Step™ Biopsy Device System
DESCRIPTION OF THE DEVICE 4.
The Single Step™ Biopsy Device is an electrosurgical cutting instrument which uses radio frequency (RF) energy to localize a breast lesion and cut a sample of breast tissue for diagnostic biopsy.
STATEMENT OF INTENDED USE 5.
The Single Step™ Biopsy Device System is intended for breast lesion localization and diagnostic tissue sampling for histological examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
6. COMPARISON WITH PREDICATE DEVICES
The intended use, design, construction, materials and technology are comparable to the predicate devices.
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRX, Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K021707
Trade/Device Name: Single Step™ Biopsy Device System Regulation Number: 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: May 22, 2002 Received: May 23, 2002
Dear Ms. Boucly:
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. Amy Boucly
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Hytl Rhodes
Celia M. Witten, Ph.D., M.D.
M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SenoRx Inc. Premarket Notification Single Step™ Biopsy Device System
. . .
FDA Indications for Use Page 2
510(k) number (if known): __ ヒロスクグフ
Device Name:
Single Step™ Biopsy Device System
Indications for Use:
The Single Step™ Biopsy Device System is intended for breast lesion localization and diagnostic tissue sampling for histological examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | ✓ |
OR
| Over-The-Counter Use | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number: | K021707 |
2
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.