(70 days)
Not Found
No
The summary describes an electrosurgical device for breast tissue sampling and excision, with no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No.
The device is used to obtain tissue samples for diagnostic sampling and histologic examination, not to treat a disease or condition. It is classified as an Electrosurgical Cutting & Coagulation Device and a Biopsy Instrument.
Yes
The device is intended to provide tissue samples for diagnostic sampling of breast abnormalities, and this tissue is used for histologic examination, which is a diagnostic process.
No
The device description explicitly states "Electrosurgical Generator" and "Breast Lesion Excision System (BLES)", indicating a hardware device used for tissue excision, not a software-only application.
Based on the provided information, the intact™ BLES is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to obtain tissue samples for diagnostic sampling and histologic examination. It is a tool for tissue acquisition, not for performing the diagnostic test itself.
- Device Description: The device is classified as an "Electrosurgical Cutting & Coagulation Device & Accessories" and a "Biopsy Instrument." These classifications are for devices used in surgical procedures to obtain tissue, not for analyzing biological samples in vitro.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or treatment. The intact™ BLES is used within the body to collect the specimen.
The tissue samples obtained by the intact™ BLES would then be sent to a laboratory for in vitro diagnostic testing (histologic examination), but the intact™ BLES itself is the instrument used to collect the sample.
N/A
Intended Use / Indications for Use
The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. 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
KNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003190, K021577, K020031, K042170, K050737, K052246, K003297
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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510(k) SUMMARY
Intact Medical Corporation's intact "M Breast Lesion Excision System (BLES)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
David Jacobs VP. Engineering Intact Medical Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239
7 233
Date Prepared: February 14, 2005
Name of Device and Name/Address of Sponsor
| Common or Usual Name: | Electrosurgical Generator |
|---|---|
| Trade or Proprietary Name: | intact™ Breast Lesion Excision System (BLES) |
| Classification Name: | Electrosurgical Cutting & Coagulation Device & |
| Accessories (21 C.F.R. § 878.4400) | |
| Biopsy Instrument (21 C.F.R. § 876.1075) | |
| Intact Medical Corporation |
One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239
Predicate Devices
Intact Medical Corporation's intact™ BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297).
Intended Use
The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial
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removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ BLES may also be used to partially remove such palpable lesions. Whenever treast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examind for completeness of removal using standard surgical procedures.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 2 7 2006
Intact Medical Corporation c/o Mr. David Jacobs VP, Engineering One Apple Hill. Suite-316 Natick, Massachusetts 01760
Re: K060413
Trade/Device Name: intact™ Breast Lesion Excision System (BLES) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 7, 2006 Received: April 11, 2006
Dear Mr. Jacobs:
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
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Page 2 - Mr. David Jacobs
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 (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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Indications for Use
510(k) Number (if known):
Device Name: intact™ Breast Lesion Excision System (BLES)
Indications For Use:
The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. 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 AND/OR (Part 21 CFR 801 Subpart D)
R Over-The-Co
(21 CFR 807 Sub
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOGO413