(432 days)
Not Found
No
The summary describes a mechanical biopsy device and its performance in nonclinical studies, with no mention of image processing, AI, or ML.
No.
The device is used for diagnostic sampling of breast abnormalities, not for treatment or therapy.
Yes
The device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities, and these samples are used for histologic examination to determine the nature of the abnormality. This directly supports the diagnostic process.
No
The device description explicitly states it is an "electrosurgical breast tissue biopsy device," indicating it is a hardware device that performs a physical action (tissue biopsy) using electrical energy.
Based on the provided information, the Chest Innovations' SureCore™ Biopsy Device is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is to "provide breast tissue samples for diagnostic sampling of breast abnormalities." This tissue is then used for "histologic examination," which is a laboratory test performed in vitro (outside the body) to diagnose diseases.
- Purpose: The device's function is to obtain a biological specimen (breast tissue) that will be analyzed in vitro to provide diagnostic information.
While the device itself is used in vivo (within the body) to collect the sample, its purpose is directly tied to the subsequent in vitro diagnostic testing of that sample. This aligns with the definition of an IVD device, which includes instruments and reagents intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW, GEI
Device Description
The SureCore™ Biopsy Device is an electrosurgical breast tissue biopsy device that is shipped sterile and intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammographic appearance
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SureCore™ Biopsy Device performance characteristics were evaluated in the following nonclinical studies: device tensile strength, in-vitro device performance, electrical safety, electromagnetic compatibility, electrical safety for endoscopic equipment, sterility testing, shelf life testing, biocompatibility and in-vivo animal device performance.
Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the SureCore™ Biopsy Device meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the SureCore™ Biopsy Device is substantially equivalent to the named predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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/u2756
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name, Address, Phone and Fax Number of Applicant
Chest Innovations, Inc. 827 Canoas Creek Circle San Jose, CA 95136 Phone: (408) 826-9740 Fax: (408) 448-4615
B. Contact Person
Salmaan Hameed Chief Executive Officer Phone: (408) 826-9740 salmaan.hameed@sbcglobal.net
Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net
C. Date Prepared
November 28, 2011
D. Device Name
| Trade Name: | SureCore™ Biopsy Device | ||
|---|---|---|---|
| Common Name: | Biopsy Instrument | ||
| Classification Name: | Biopsy Instrument (21 CFR§ 876.1075, Product Code | ||
| KNW) | |||
| and | |||
| Electrosurgical, Cutting & Coagulation & Accessories | |||
| (21 CFR§878.4400, Product Code GEI) |
E. Predicate Devices
The SureCore™ Biopsy Device is substantially equivalent to:
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/o2 756
- Neothermia Corporation en-bloc® Biopsy System K050737 cleared March 31. O 2005
- o Angiotech BioPince™ Ultra Full Core Biopsy Instrument K101832 cleared August 27, 2010
ட் Device Description
The SureCore™ Biopsy Device is an electrosurgical breast tissue biopsy device that is shipped sterile and intended for single use.
G. Intended Use
The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic 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.
| Manufacturer | Chest Innovations | Neothermia Corporation | Angiotech |
|---|---|---|---|
| Device Name | SureCore™ Biopsy Device | en-bloc ®Biopsy | BioPince™ Ultra Full Core Biopsy Instrument |
| 510(k) Number | K102756 | K050737 | K101832 |
| Intended Use | provide tissue samples for diagnostic sampling of breast abnormalities. | provide tissue samples for diagnostic sampling of breast abnormalities. | multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions. |
| Product Code | KNW; GEI | GEI | KNW |
| Mechanism of Action | radiofrequency energy to cut the tissue during open surgical or endoscopic procedures | radiofrequency energy to cut the tissue during open surgical or image guided procedures | mechanical cutter to cut the tissue during percutaneous, open surgical or endoscopic procedures |
H. Technological Comparison
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| Sample Size | ||
|---|---|---|
| Cylindrical, full core | ||
| specimen | Cylindrical, full core | |
| specimen | Cylindrical, full core | |
| specimen | ||
| 2.4 mm Diameter x 10-20 | ||
| mm | 10mm wand: 12mm x13mm | |
| 12mm wand 13mm x 17mm | ||
| 15mm wand: 14mm x 18mm | ||
| 20mm wand:18 mm x 18 mm | 1.3mm-1.6mm Diameter. | |
| The 13mm stroke length | ||
| yields a specimen of 9mm | ||
| length, the 23mm stroke | ||
| length yields a specimen of | ||
| 19mm length, and the | ||
| 33mm yields a specimen of | ||
| 29mm length. | ||
| Average Tissue | ||
| Volume | ||
| 37.9 mm3 (2.4mm with | ||
| 10mm stroke length) | 1470.9mm3 (10mm wand)' | |
| 2257.4mm3 (12 mm wand) | ||
| 2772.0mm3 (15 mm wand) | ||
| 4582.3mm3 (20 mm wand) | 16.5 mm3 (1.6mm diameter | |
| device with 13mm stroke | ||
| length) | ||
| Profile | ||
| 10.5G 24 cm long | 5.3 mm Shaft Diameter | |
| 11.6 cm long | 14G, 16G, 18G and 20G | |
| needle sizes 10cm, 15cm | ||
| and 20cm lengths | ||
| Energy Type | ||
| RF Valley Lab Force II | ||
| Generator | Proprietary Generator, | |
| NeoThermia™ Model 3000 | Mechanical, spring | |
| mechanism for firing of | ||
| needle. | ||
| Power | ||
| Standard 120 V | Standard 120 V | N/A |
| Electrical Energy | ||
| Delivered | ||
| Monopolar Radio Frequency | ||
| 510 kHz Sinusoidal wave, | ||
| Max 65 Watts | Monopolar Radio Frequency | |
| 350 kHz Sinusoidal wave, | ||
| Max 250 watts | N/A |
l. Summary of Non-Clinical Data
SureCore™ Biopsy Device performance characteristics were evaluated in the following nonclinical studies: device tensile strength, in-vitro device performance, electrical safety, electromagnetic compatibility, electrical safety for endoscopic equipment, sterility testing, shelf life testing, biocompatibility and in-vivo animal device performance.
Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the SureCore™ Biopsy Device meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the SureCore™ Biopsy Device is substantially equivalent to the named predicates.
J. Summary of Data
The SureCore™ Biopsy Device has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the SureCore™ Biopsy Device performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the SureCore™ Biopsy Device is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.
1 Intact™Specimen Capture Volumes@2005 Intact Medical Corporation. ML082, Rev. 0
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
NOV 2 9 2011
Chest Innovations, Inc. % Mr. Salmaan Hameed Chief Executive Officer 827 Canoas Creek Circle San Jose, California 95136
Re: K102756
Trade/Device Name: SureCore™ Biopsy Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, KNW Dated: November 11, 2011 Received: November 14, 2011
Dear Mr. Hameed:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Mr. Salmaan Hameed
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours. Mark N. Melke rson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K102756
Device Name: Chest Innovations, Inc. SureCore™ Biopsy Device
INDICATIONS FOR USE
The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (Part 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)
Nel R.F. Ogle for mxm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K102756