(112 days)
Not Found
No
The summary describes a mechanical surgical access device and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an "access device indicated for use [...] to provide a passageway for the introduction of endoscopic instruments." It facilitates a procedure but does not directly treat a medical condition or disease.
No
The device description clearly states it 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." It is a surgical instrument for access and not designed to diagnose conditions.
No
The device description explicitly states it is a reusable stainless steel endoscopic instrument, which is a hardware component.
Based on the provided text, 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 during laparoscopic procedures. This is a surgical access device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a reusable stainless steel cannula and obturator used for surgical access. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text 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 use
The device is clearly described as a surgical instrument used for creating and maintaining a port of entry during surgery.
N/A
Intended Use / Indications for Use
The reusable FloShield 10mm Endoscopic Cannula and 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 (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The FloShield 10mm Endoscopic Cannula and Blunt Obturator are re-usable stainless steel endoscopic instruments delivered non-sterile 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 is a Hasson style, blunt tip obturator that 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance and functional testing of the FloShield 10mm Endoscopic Cannula and 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.
The intended use and performance parameters of the FloShield 10mm Endoscopic Cannula and Blunt Obturator are similar or equivalent to the characteristics of the Karl Storz 10mm Reusable Trocar with Hasson Style Obturator (K943713, K943897), the daVinci Si 8.5mm Reusable Accessory Cannula (K122532), and the daVinci Si 10mm Reusable Accessory Cannula (K122532) as determined in Section 12.0 of this Premarket Notification (510(k)) submission.
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
§ 876.1500 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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2014
Minimally Invasive Devices Incorporated Ms. Trudie L. Seeger Vice President of Regulatory, Quality and Clinical Affairs 1275 Kinnear Road Columbus, Ohio 43212
Re: K141272
Trade/Device Name: FloShield 10mm Endoscopic Cannula and Blunt Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 26, 2014 Received: August 27, 2014
Dear Ms. 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
1
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 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/Resourcesfor You/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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K141272
Device Name
FloShield 10mm Endoscopic Cannula and Blunt Obturator
Indications for Use (Describe)
The reusable FloShield 10mm Endoscopic Cannula and 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)
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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:
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Image /page/3/Picture/0 description: The image shows the logo for "minimally invasive devices, inc.". The logo consists of the letters "mid" in a stylized font, with a small orange dot above the "i". Below the letters, in a smaller font, is the text "minimally invasive devices, inc."
510(k) Summary (21 CFR §807.92(c))
| 510(k) Number: | K141272 |
|---|---|
| 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: | 08 Aug, 2014 |
| Device Trade Name: | FloShield 10mm Endoscopic Cannula and Blunt Obturator |
| Common Name: | Cannula and Obturator |
| Classification Name: | Laparoscope, General & Plastic Surgery (21 CFR §876.1500) |
| Product Code: | GCJ |
| Predicate Devices: | Karl Storz 10mm Reusable Trocar with Hasson Style Obturator |
| (K943713, K943897) | |
| daVinci Si 8.5mm Reusable Accessory Cannula (K122532) | |
| daVinci Si 10mm Reusable Accessory Cannula (K122532) |
Device Description:
The FloShield 10mm Endoscopic Cannula and Blunt Obturator are re-usable stainless steel endoscopic instruments delivered non-sterile 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 is a Hasson style, blunt tip obturator that facilitates the insertion of the cannula through an incision site.
510(k) Summary Page 1 of 3
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Image /page/4/Picture/0 description: The image shows the logo for "mid minimally invasive devices, inc.". The logo is in lowercase letters and the letters are rounded. There is a dot above the "i" in "mid". The text "minimally invasive devices, inc." is in a smaller font size and is located below the word "mid".
Intended Use/Indications for Use:
The reusable FloShield 10mm Endoscopic Cannula and 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 Blunt Obturator has the same design, materials and intended use as the Karl Storz 10mm Reusable Trocar with Hasson Style Obturator (K943713, K943897), the daVinci Si 10mm Reusable Accessory Cannula (K122532) and the daVinci Si 8.5mm Reusable Accessory Cannula (K122532).
Technological Characteristics:
The technological characteristic of the FloShield 10mm Endoscopic Cannula and Blunt Obturator are very similar to the predicate devices. All cannulas are 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). The Karl Storz 10mm Reusable Trocar has an additional stopcock valve in its Luer fitting and has a reusable gas and instrument seal. The FloShield 10mm Endoscopic Cannula, daVinci Si 8.5mm Reusable Accessory Cannula (K122532), and the daVinci 10mm Reusable Accessory Cannula all use the disposable 8.5 - 13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The obturators function identically (i.e., facilitates the insertion of the cannula through an incision site) with the only difference being that the Karl Storz Hasson Style Obturator is a concal blunt obturator and the FloShield Blunt Obturator and the da Vinci Blunt Obturator are full blunt Hasson obturators. FloShield Blunt Obturator and the Karl Storz Hasson Style Obturators are made of stainless steel and the daVinci Blunt Obturator is made of plastic all devices will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter).
510(k) Summarv Page 2 of 3
Performance Testing:
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Image /page/5/Picture/0 description: The image shows the logo for "minimally invasive devices, inc.". The logo consists of the letters "mid" in a stylized font, with the words "minimally invasive devices, inc." written in a smaller font below the letters. The letters and words are in gray color.
The performance and functional testing of the FloShield 10mm Endoscopic Cannula and 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.
Conclusion Drawn from Tests and Analyses:
The intended use and performance parameters of the FloShield 10mm Endoscopic Cannula and Blunt Obturator are similar or equivalent to the characteristics of the Karl Storz 10mm Reusable Trocar with Hasson Style Obturator (K943713, K943897), the daVinci Si 8.5mm Reusable Accessory Cannula (K122532), and the daVinci Si 10mm Reusable Accessory Cannula (K122532) as determined in Section 12.0 of this Premarket Notification (510(k)) submission.
510(k) Summary Page 3 of 3