(139 days)
The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.
The Manoa Breast Biopsy System is comprised of a sheath introducer, a tissue cutter, a specimen retriever and an electrosurgical cable. The Manoa Breast Biopsy System is a minimally invasive biopsy device designed to penetrate, cut and collect an intact tissue specimen during a biopsy procedure.
This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in clinical trial reports.
Therefore, the provided text does not contain the detailed information required to fill out the requested table and answer many of the specific questions about acceptance criteria, study design, and performance metrics.
Here's what can be inferred and what is missing based on the provided text:
Missing Information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Inferred Information (limited):
From the context of a 510(k) submission for an "Electrosurgical Cutting and Coagulation Device and Accessories (Breast Biopsy Device)", the "performance" typically refers to engineering performance, safety, and functionality, rather than diagnostic accuracy or concordance with a clinical ground truth, which would be the focus for an AI/CADe device.
The study that "proves" the device meets acceptance criteria in a 510(k) context usually refers to a battery of tests demonstrating physical, electrical, and biocompatibility safety and performance, as well as functional equivalence to predicate devices. The document explicitly mentions "biosafe materials which are ISO 10993-1 compliant for their intended patient contact profile," which is a statement about materials performance and safety.
Given the information in the provided 510(k) summary, it's not possible to populate the requested table or answer the specific questions about clinical or AI performance. The document focuses on device description, indications for use, predicate devices for substantial equivalence, and regulatory classification.
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510(k) Summary of Safety and Effectiveness F.
This 510(k) summary of safety and effectivencss information is submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
| SUBMITTER: | Manoa Medical, Inc.1017 El Camino #361Redwood City, CA 94063Phone: 408-666-1413Fax: 650-365-8340 | |
|---|---|---|
| CONTACT PERSON: | Niyazi Beyhan | |
| DATE PREPARED: | September 30, 2003 | |
| CLASSIFICATION NAME: | Electrosurgical Cutting and Coagulation Deviceand Accessories (21 CFR 870.4400) | |
| COMMON NAME: | Breast biopsy device | |
| PROPRIETARY NAME: | Not Yet Determined | |
| PREDICATE DEVICES: | Rubicor Medical, Inc.: EnCapsuleEthicon-Endosurgery: Mammotome Hand-HeldSenoRx: Easy GuideValleylab: Coated ElectrodesImagyn: SiteSelect | |
| DEVICE DESCRIPTION: | The Manoa Breast Biopsy System is comprisedof a sheath introducer, a tissue cutter, aspecimen retriever and an electrosurgical cable.The Manoa Breast Biopsy System is aminimally invasive biopsy device designed topenetrate, cut and collect an intact tissuespecimen during a biopsy procedure. | |
| INDICATIONS FOR USE: | The Manoa Breast Biopsy System is intendedfor diagnostic sampling of breast tissue during abreast biopsy procedure. It is for diagnosticpurposes only and is not intended fortherapeutic use. | |
| MATERIALS: | The Manoa Breast Biopsy System is composedof biosafe materials which are ISO 10993-1compliant for their intended patient contactprofile. | |
| 510(k) Premarket Notification | Manoa Medical, Inc. | Page 13 |
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Manoa Medical, Inc.
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Image /page/1/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of a human figure with three heads, symbolizing health, human services, and the public. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2004
Roberta Lee, M.D. Founder & CLO Manoa Medical, Inc. 1017 El Camino PMB 361 Redwood City, California 94063
Re: K033205
Trade/Device Name: Manoa Breast Biopsy System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 29, 2003 Received: January 2, 2004
Dear Dr. Lee:
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. Iisting 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 - Roberta Lee, M.D.
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 (301) 594-4659. Also, please note the regulation entitled, "Mishranding 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N. Melleman
Celia 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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510(k) Number (if known): K033205
Name: Manoa Breast Biopsy System
Indications for Use:
Indications for Use
E.
The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.
Prescription Use: X (Per 21 CFR 801.109)
OR
Over-The-Counter Use:
(Please do not write below this line - continue on another page if needed.)
'DRH, Office of Device Evaluation (ODE) 11/2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K033305
(Division Sign-Off) Division of General Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
510(k) Premarket Notification
Manoa Medical, Inc.
Page 12
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Manoa Medical, Inc.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.