CORAMATE/SPIROTOME SYSTEM

{0}------------------------------------------------ APR 11 2008 ### 510 (k) Summary Medinvents NV 510 (k) Premarket Notification for Coramate/Spirotome K080095 ### Premarket Notification 510(k) Summary (per 21 CFR 807.92) Coramate/Spirotome System Submitted by: Magda Buttiens CEO Medinvents B-3500 Hasselt - Belgium Phone: +3211271557 Fax: +3211283677 Email: magda.buttiens@medinvents.com Date prepared: February 25, 2008 Device Name: Trade Name: Coramate/Spirotome system Classification Name: Biopsy Needle ### Predicate Devices: | Organ | Predicate device | ID-PD | 510 (k) application | Remarks | |-------------------------|---------------------------|---------|------------------------|---------| | Skin | Punch Biopsy needle | K896303 | Spirotome (Easy Punch) | | | Vulva | Punch Biopsy needle | K896030 | Spirotome (Easy Punch) | | | Breast | Mammotome | K033700 | Spirotome/Coramate | K060384 | | Lymph node | Tru-cut needle | K024120 | Spirotome/Coramate | | | Thyroid, salivary gland | Tru-cut needle | K024120 | Spirotome/Coramate | | | Salivary gland | Tru-cut needle | K024120 | Spirotome/Coramate | | | Liver | Tru-cut needle | K024120 | Spirotome/Coramate | | | Cervix | Forceps | K842112 | Spirotome Cervicore | | | Muscle | Tru-cut needle | K024120 | Spirotome/Coramate | | | Abdominal wall | Tru-cut needle | K024120 | Spirotome/Coramate | | | Thoracic wall | Tru-cut needle | K024120 | Spirotome/Coramate | | | Bone | Bone marrow biopsy needle | K001132 | Spirotome Bone | | ### Device Description: The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from the human body. The Coramate/Spirotome system consists of 2 major components: the set of needles (Spirotome) and a powered device that operates the needles (Coramate). The set of needles can be operated manually as well (single-use and reusable Spirotome). The needle set contains 3 needles that work in conjunction. {1}------------------------------------------------ Ko80095 Page 2 of 3 ## Intended Use | Device Name | Indications for Use | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Coramate system | The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate<br>samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and<br>parotis.<br>The Coramate system is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of imaged abnormalities.<br>The Coramate system is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of palpable abnormalities.<br>An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant<br>disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of<br>benignancy or malignancy and to characterize as complete as possible the nature of the lesion without<br>unnecessary discomfort to the patient.<br>In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or<br>hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be<br>provided. | | Spirotome system | The Spirotome system is a family of core soft tissue biopsy medical devices to be used in humans to take out<br>adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph<br>nodes, thyroid, parotis, muscles and liver.<br>The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of imaged abnormalities.<br>The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of palpable abnormalities.<br>An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant<br>disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of<br>benignancy or malignancy and to characterize as complete as possible the nature of the lesion without<br>unnecessary discomfort to the patient.<br>In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or<br>hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be<br>provided. | | Cervicore system | The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out<br>adequate samples of tissue from the human cervix.<br>The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of imaged abnormalities by inspection or colposcopy.<br>The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of palpable abnormalities.<br>An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant<br>disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of<br>benignancy or malignancy and to characterize as complete as possible the nature of the lesion without<br>unnecessary discomfort to the patient.<br>In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or<br>hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be<br>provided. | | Easy Punch Spirotome | The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out<br>adequate samples of tissue from the skin.<br>The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation<br>of imaged abnormalities.<br>The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation<br>of palpable abnormalities.<br>An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant<br>disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of<br>benignancy or malignancy and to characterize as complete as possible the nature of the lesion without<br>unnecessary discomfort to the patient.<br>In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or<br>hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be<br>provided. | | Spirotome Bone | The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out<br>adequate samples of soft tissue from bony structures.<br>The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and<br>confirmation of imaged abnormalities.<br>An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant<br>disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of<br>benignancy or malignancy and to characterize as complete as possible the nature of the lesion without<br>unnecessary discomfort to the patient.<br>In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or<br>hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be<br>provided. | {2}------------------------------------------------ Ko80095 page 3 of 3 ### Technological Characteristics The Coramate/Spirotome system is identical to the currently marketed macrobiopsy systems (K060384). It contains a needle set and a hand held powered device based on the same concept. In addition, substantial equivalence is noted towards the intended use in other soft tissue systems of the human body. The basic system is a radial cutting of a cutting cannula on a helicoidal shaped receiving element. This system can be operated manually, whereby the system is advanced by the aid of a trocar needle up to the diseased area. Combined, this needle set is called the Spirotome and can be delivered single-use or as a reusable device. The Coramate is a powered device that operates the same needles automatically. The interface with the patient is the same both in the Coramate and Spirotome: i.e. the intenate set. In addition, the Coramate includes a vacuum to the needles for maximal performance. The Coramate contains a combination of interfaces, motors and software in addition to a battery with loader. The interfaces fix the needle set into the device. in addition to a batter, form the necessary movements of the needles. The software guides the motors into smooth and ordered movements of the needles. The batteries galled the heater Accessories may be added to the system: e.g. releasing element, spacer, protecting ring, and battery loader. ### Performance data Thorough preclinical testing was performed to ensure the device performs as intended. In particular most laboratory and preclinical testing was done on animal tissues to ensure maximum performance in the human situation. Clinical testing indicates that all performance and safety aims are reached. Since the interface of the system is the same in the Spirotome compared to the Coramate, all the inical evidence gained by the Spirotome is relevant to the Coramate. Most of the clinical work has been done in human breast tissues as has been published in international PEER reviewed Journals and Meetings. In addition, recent clinical international + LLN relating to the performance in various other soft tissues than the breast. In summary, all this clinical data indicate that the Coramate and the brough " if our " " on as intended, with aimed performance and maximal safety and similar to the 'Indications for Use' of the predicate device. In particular, no complication was noted up to now in the clinical tests and subsequent vigilance quality control follow-up. Control one and Coramate devices comply with the European Medical Device Directive 92/42/EEC and clearance was given for all soft tissues of the human body. All requested standard testing according to the claims made have been done. ### Conclusion Oonclusion Based upon the tooting and companser soft tissues than the breast was substantially the Oblamatoropirotomo of the predicate devices. The system performs as intended and raises no new safety or effectiveness issues. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 1 1 2008 MedInvents % Mr. Jaak Janssens Klein Hillststraat 5 Hasselt, Limburg Belgium 3500 Re: K080095 Trade/Device Name: Coramate system Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 6, 2008 Received: March 17, 2008 Dear Mr. Janssens: 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. {4}------------------------------------------------ Page 2 - Mr. Jaak Janssens 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 yours, Mark A. Mulhern Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K080095 Page 25 of 64 pages Page 1 of 5 ### Coramate needle ### Indications for Use 510(k) Number (if known): K080095 Device Name: Coramate system Indications For Use: The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and parotis. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided. Prescription Use (Part 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) {6}------------------------------------------------ Ko80095 Page 26 of 64 pages ### Spirotome needle #### Indications for Use ### 510(k) Number (if known): K080095 Device Name: Spirotome system #### Indications For Use: The Spirotome system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles and liver. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided. Prescription Use (Part 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) {7}------------------------------------------------ Page 27 of 64 pages Ko 80095 Page 3 of 5 Cervicore needle Indications for Use 510(k) Number (if known): K080095 Device Name: Cervicore Spirotome #### Indications For Use: The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the human cervix. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities by inspection or colposcopy. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided. Prescription Use *X* (Part 21 CFR 801 Subpart D) AND/OR Over-The Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE) Nil RP Gln for mam Division of General, Restorative, and Neurological Devices K080095 510(k) Number_ {8}------------------------------------------------ Ko80095 Page 28 of 64 pages Page 4 of 5 Easy Punch Indications for Use 510(k) Number (if known): K080095 Device Name: Easy Punch Spirotome Indications For Use: The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the skin. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided. 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-CONTINU ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R.P. Ogle firman Division of General. Restorative. and Neurological Devices 510(k) Number K080095 {9}------------------------------------------------ Page 29 of 64 pages Kofoo 95- Spirotome Bone Page 5 of 5- Indications for Use ### 510(k) Number (if known): K080095 Device Name: Spirotome Bone ### Indications For Use: The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from bony structures. The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided. Prescription Use (Part 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE)