(26 days)
No
The device description and performance studies focus on mechanical and functional aspects of a surgical access device, with no mention of AI/ML capabilities or data processing.
No
The device is described as an "access device" that provides a passageway for surgical instruments. It does not directly treat or diagnose a disease or condition.
No
The device description clearly states it is an "access device indicated for use with a disposable ... Cannula Seal ... to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures." Its purpose is to facilitate access for surgical instruments, not to diagnose conditions.
No
The device description explicitly states it is a "re-usable stainless steel endoscopic instrument" and describes physical components like a cannula, obturator, and luer fitting. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a reusable stainless steel cannula and obturator used in surgery. It does not mention any components or processes related to testing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic information
- Laboratory setting for testing
The device is clearly described as a surgical instrument used for accessing the body during laparoscopic procedures.
N/A
Intended Use / Indications for Use
The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.
Product codes
GCJ
Device Description
The FloShield 10mm Endoscopic Conical Blunt Obturator is a re-usable stainless steel endoscopic instrument delivered non-sterile with the FloShield 10mm Endoscopic Cannula to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 -13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator has a conical blunt style tip which facilitates the insertion of the cannula through an incision site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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
The performance and functional testing of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator included tests to verify its ability to create and maintain a port of entry during simulated laparoscopic surgery, its ability to maintain pneumoperitoneum during the course of surgery and comparable functional characteristics to the predicates (Leak Resistance, Insufflating Flow Rates, Insertion and Removal Force, Snap Retention).
Sterilization validation for reusable devices was successfully performed in accordance with ISO 17665: 2006 Sterilization of Healthcare Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices and ANSI/AAMI ST81:2004 (R2010): Sterilization of Medical Devices - Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
Minimally Invasive Devices Incorporated Dr. Trudie L. Seeger, Ph.D. Vice President of Regulatory, Quality and Clinical Affairs 1275 Kinnear Avenue Columbus, Ohio 43026
Re: K150705
Trade/Device Name: FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 16, 2015 Received: March 18, 2015
Dear Dr. Seeger:
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 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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator
Indications for Use (Describe)
The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the logo for "mid minimally invasive devices, inc.". The logo is in a light gray color. The letters "mid" are connected at the bottom by small orange circles.
Minimally Invasive Devices Inc 1275 Kinnear Road Columbus, Ohio 43212
510(k) Summary (21 CFR §807.92(c))
| 510(k) Number: | K150705 |
|---|---|
| Submitter: | Minimally Invasive Devices, Inc. |
| 1275 Kinnear Road | |
| Columbus, Ohio 43212 | |
| Contact: | Trudie L. Seeger, Ph.D. |
| V.P., Regulatory/Quality/Clinical Affairs | |
| Telephone: 614-484-5036 | |
| Fax: 614-484-5034 | |
| E-mail: tseeger@midsurgical.com | |
| Date Summary Prepared: | 18 Feb, 2015 |
| Type of Submission: | Special 510(k) |
| Device Trade Name: | FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator |
| Common Name: | Cannula and Obturator |
| Classification Name: | Laparoscope, General & Plastic Surgery (21 CFR §876.1500) |
| Product Code: | GCJ |
| Predicate Devices: | FloShield 10mm Endoscopic Cannula and Blunt Obturator |
| (K141272) |
Device Description:
The FloShield 10mm Endoscopic Conical Blunt Obturator is a re-usable stainless steel endoscopic instrument delivered non-sterile with the FloShield 10mm Endoscopic Cannula to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 -13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator has a conical blunt style tip which facilitates the insertion of the cannula through an incision site.
510(k) Summary Page 1 of 3
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Minimally Invasive Devices Inc 1275 Kinnear Road Columbus, Ohio 43212
Intended Use/Indications for Use:
The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.
Comparison to Predicate Devices:
The FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator has the same design, materials and intended use as the FloShield 10mm Endoscopic Cannula and Blunt Obturator (K141272).
Technological Characteristics:
The technological characteristic of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator are very similar to the predicate device. The FloShield 10mm Endoscopic Cannula is the same cannula used in the predicate device. The FloShield 10mm Endoscopic Cannula is stainless steel and reusable. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter) and uses the disposable 8.5 = 13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel obturators are functionally identical (i.e., facilitates the insertion of the cannula through an incision site) with the only difference being that the FloShield Conical Blunt Obturator is a Hasson Style conical blunt obturator and the FloShield Blunt Obturator is a full blunt Hasson obturators.
Performance Testing:
The performance and functional testing of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator included tests to verify its ability to create and maintain a port of entry during simulated laparoscopic surgery, its ability to maintain pneumoperitoneum during the course of surgery and comparable functional characteristics to the predicates (Leak Resistance, Insufflating Flow Rates, Insertion and Removal Force, Snap Retention).
510(k) Summary Page 2 of 3
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Minimally Invasive Devices Inc 1275 Kinnear Road Columbus, Ohio 43212
Sterilization validation for reusable devices was successfully performed in accordance with ISO 17665: 2006 Sterilization of Healthcare Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices and ANSI/AAMI ST81:2004 (R2010): Sterilization of Medical Devices - Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Conclusion Drawn from Tests and Analyses:
The intended use and performance parameters of the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator are similar or equivalent to the characteristics of the FloShield 10mm Endoscopic Cannula and Blunt Obturator (K141272) as determined in Section 11.0 of this Premarket Notification (510(k)) submission.
510(k) Summary Page 3 of 3