(64 days)
Not Found
No
The provided text describes a tissue sampling device and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is indicated for diagnostic sampling of breast abnormalities and tissue removal for histologic examination, not for treating a disease or condition.
Yes
The device is indicated to provide tissue samples for "diagnostic sampling of breast abnormalities" and for "histologic examination," which is a diagnostic process.
No
The intended use and predicate device descriptions strongly suggest a physical device for tissue excision, not a software-only solution. The lack of any mention of software, image processing, or AI further supports this conclusion.
Based on the provided information, the Intact Excision XL is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens outside the body. They analyze things like blood, urine, tissue samples, etc., to provide information about a patient's health.
- The Intact Excision XL is a device used within the body to obtain tissue samples. Its purpose is to physically remove breast tissue for subsequent examination.
The Intended Use clearly states that the device is used to "provide tissue samples for diagnostic sampling" and "provide breast tissue for histologic examination." This means the device is a tool for collecting the sample, not for performing the diagnostic test itself. The diagnostic testing (histologic examination) happens after the tissue is removed using this device.
Therefore, the Intact Excision XL is a surgical or biopsy device, not an IVD.
N/A
Intended Use / Indications for Use
The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The Intact Excision XL 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 System 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
Electrosurgical Generator
Intact® Excision XL
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)
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.
0
510(k) SUMMARY
Intact Medical Corporation's Intact® Excision XL
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Doug Macarthur Senior Director of Engineering Intact Medical Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239
Date Prepared: April 11, 2008
Name of Device and Name/Address of Sponsor
Common or Usual Name:
Electrosurgical Generator
Intact® Excision XL
Trade or Proprietary Name:
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 (formerly Neothermia) Corp.'s Intact BLES and Intact® Advance (formerly enbloc Biopsy) System (K060413).
Intended Use
The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The Intact Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
1
The Intact Excision XL 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™ system 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2008
Intact Medical Corporation % Mr. Doug Macarthur Senior Director of Engineering One Apple Hill, Suite 316 Natick, Massachusetts 01760
Re: K081057
Trade/Device Name; Intact® Excision XL Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 11, 2008 Received: April 14, 2008
Dear Mr. Macarthur:
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.
3
Page 2 - Mr. Doug Macarthur
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 the reporting 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 vours.
Mark W. Miller
- 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
K081057 510(k) Number (if known):
Device Name: Intact® Excision XL
Indications For Use:
The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The Intact Excision XL 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 System 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil R. d. for man
Clerk
Division of General, Restorative, and Neurological Devices
510(k) Number K081057