MIDSLEEVE
Device Facts
| Record ID | K142548 |
|---|---|
| Device Name | MIDSLEEVE |
| Applicant | Medical Innovation Development |
| Product Code | KNT · Gastroenterology, Urology |
| Decision Date | Jun 23, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
Device Story
MIDSLEEVE is a sterile, single-use silicone calibration tube (37.5 French diameter, 900 mm length) used during Longitudinal Sleeve Gastrectomy. Device features include a proximal PVC valve, distal side holes for suction, and an asymmetric inflatable balloon. Surgeon inserts deflated tube into stomach; balloon is inflated with 10-50cc of air or saline to delineate the gastric antrum. Once positioned, balloon provides tactile/visual calibration for stapling and dissection of the gastric pouch. Device allows for simultaneous suction and leak testing. Used in hospitals/surgery centers by surgeons. Benefits include optimized gastric pouch sizing, potentially improving weight loss outcomes and patient quality of life.
Clinical Evidence
Bench testing only. Conformance to ISO 11607-1/2 (packaging), ASTM F88-09 (seal strength), ASTM F1980-07 (accelerated aging), ISO 10993-1/5/10 (biocompatibility/cytotoxicity/sensitization), and ASTM F1140 (package integrity). Engineering performance testing included dimensional analysis, balloon inflation reliability, burst volume testing, and joint strength testing.
Technological Characteristics
Silicone tube, 37.5Fr diameter, 900mm length. Features: PVC valve, asymmetric inflatable balloon, distal side holes. Sterilization: Ethylene Oxide (EO). Connectivity: None. Software: None. Standards: ISO 11607, ASTM F88, ASTM F1980, ISO 10993, ASTM F1140.
Indications for Use
Indicated for individuals undergoing Longitudinal Sleeve Gastrectomy (LSG) bariatric procedures to drain gastric fluid and calibrate the gastric pouch.
Regulatory Classification
Identification
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Special Controls
*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
Medical Innovation Development % Mélanie Fouilland Quality/RA Manager 9, Chemin Du Jubin Dardilly, RHONE 69570 France
Re: K142548
> Trade/Device Name: MIDSLEEVE™ Calibration Tube for Sleeve Gastrectomy Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 11, 2015 Received: May 14, 2015
Dear Mélanie Fouilland,
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.
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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 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" (21 CFR 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 vours.
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for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142548
Device Name
MIDSLEEVE Calibration Tube for Sleeve Gastrectomy
Indications for Use (Describe)
MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
Type of Use (Select one or both, as applicable)
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."
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"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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T : +334 78 17 48 04 F : +334 72 82 91 23
# 510(k) SUMMARY
Prepared: Updated: Applicant information: Address:
### September 3rd, 2014 June 19th, 2015 Medical Innovation Développement 9, Chemin du Jubin 69570 DARDILLY FRANCE
510(k) Number : Telephone Number: Fax Number: Name of Contact Person: K142548 +334 78 17 48 04 +334 72 82 91 23 Mélanie FOUILLAND Quality/RA Manger mid@midband.fr
21 CFR 876.5980
E-mail address
Signature
Trade Name: Common Name: Device classification: Product Code: Regulation Number:
MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy Gastrointestinal tube and accessories Class II KNT
Predicate Devices:
REALIZE™ Calibration Tube K071764 Boehringer Laboratories Gastric Sizing Tube K130483
™, Calibration Tube for Sleeve
nal tube and accessories
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### 1. Device Description
MIDSLEEVE™ Calibration tube for Sleeve Gastrectomy is a sterile, single use medical device which consists of a 900 mm long, silicone tube of 37.5 French diameter, with a PVC valve at the proximal end of the tube. The tube has several holes and a rounded end, distal from the valve and an asymmetric balloon which can be filled through the valve. Reference markings are provided on the tube, from the distal end to 70 cm to locate the tube position.
Image /page/4/Figure/5 description: The image shows a medical device with several labeled parts. The parts include a balloon, a distal tip, a silicone body, distal side holes for suction, and a valve for inflation. The balloon is blue and inflated, and the distal side holes are located on a loop of tubing.
### 1.1 Intended use
MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
### 1.2 Principles of operation
The balloon is initially deflated and in contact with the silicone body (see 1. below), which enables the insertion of the tube inside the throat to reach the patient's stomach.
As air or saline solution is injected through the valve, the balloon unfolds from the silicone body, enabling the start of its inflation (2).
Image /page/4/Figure/11 description: The image contains three pictures of a blue object. The first picture is labeled with the number 1, the second picture is labeled with the number 2, and the third picture is labeled with the number 3. The third picture has a measurement of 6 cm.
When fully inflated, the balloon, specific to MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy and designed to fit the anatomy of the gastric antrum, obtains its final shape with an air or saline solution volume of 10 to 50cc (3).
This step allows for calibration of the residual gastric antrum volume: the balloon is deflated and the stomach is then stapled and dissected following the position of the tube.
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#### 1.3 Intended performance
The targeted performance levels are the following:
MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is indicated allows an intubation A through the patient's mouth and down towards the stomach,
MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy allows simpler calibration of the A gastric pouch to be preserved during sleeve gastrectomy procedure as compared to the typical method of calibration (i.e., use of a nasogastric tube) by the surgeon.
A The dimension of the preserved gastric pouch obtained after using MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy optimizes sleeve gastrectomy effectiveness (weight loss and quality of life),
MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy allows combination with a suction A system in order to drain gastric fluids and/or to perform a leak test after the stapling step.
#### 2. Predicate Device Comparison Summary
2.1 Table of comparison
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## Medical Innovation Développement 9, Chemin du Jubin
69570 DARDILLY-France
| | Proposed device | Predicate devices | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary<br>Name | MIDSLEEVE™, Calibration Tube<br>for Sleeve Gastrectomy | REALIZE™ Gastric Calibration Tube | Boehringer Laboratories Gastric Sizing<br>Tube |
| 510(k) Number | K142548 | K 071764 | K 130483 |
| Device Common<br>Name | Gastrointestinal Tube and<br>Accessories | Gastrointestinal tubes | Gastrointestinal Tube and Accessories |
| Device Classification<br>Name | Tubes, Gastrointestinal (and<br>Accessories) | Tubes, Gastrointestinal (and<br>Accessories) | Tubes, Gastrointestinal (and<br>Accessories) |
| Manufacturer | Medical Innovation Développement | Obtech Medical SARL | Boehringer Laboratories, LLC |
| Product Code | KNT | KNT | KNT |
| FDA Regulation<br>Number | 21 CFR 876.5980 | 21 CFR 876.5980 | 21 CFR 876.5980 |
| Device Classification | Class II<br>510(k) Premarket Notification | Class II<br>510(k) Premarket Notification | Class II<br>510(k) Premarket Notification |
| Review Advisory<br>Committee | Gastroenterology/ Urology | Gastroenterology/ Urology | Gastroenterology/ Urology |
| | | Intended Use | |
| Indications for Use<br>Statement | MIDSLEEVE™, Calibration Tube<br>for Sleeve Gastrectomy is indicated<br>for use in the bariatric procedure<br>known as Longitudinal Sleeve<br>Gastrectomy (LSG), to drain &<br>remove gastric fluid and to provide<br>a calibration of the gastric pouch. | The gastric calibration tube is<br>indicated for use in gastric and<br>bariatric surgical procedures to<br>provide visible and tactile delineation<br>of the antrum of the stomach along<br>with the ability to decompress the<br>stomach, drain, and remove gastric<br>fluid and size a gastric pouch. | The Boehringer Laboratories Gastric<br>Sizing Tube is indicated for use in<br>gastric and bariatric surgical<br>procedures for the application of<br>suction, stomach decompression,<br>drainage of gastric fluids, irrigation and<br>to serve as a sizing tube. |
| Typical Use | Sleeve gastrectomy procedures | Gastric and bariatric procedures | Gastric and bariatric procedures |
| Patient Population | Individuals undergoing Longitudinal<br>Sleeve Gastrectomy procedure | Individuals undergoing bariatric and/or<br>gastric procedures | Individuals undergoing bariatric and/or<br>gastric procedures |
| Functions | Suction, drainage, sizing, irrigation | Suction, drainage, sizing, irrigation | Suction, drainage, sizing, irrigation |
| Environments of Use | Surgery Centers, Hospitals | Surgery Centers, Hospitals | Surgery Centers, Hospitals |
| Intraoperative Use | Yes | Yes | Yes |
| | | Design Characteristics | |
| Outer Diameter<br>(French) | 37.5Fr | 38Fr | 32Fr, 36Fr, or 40Fr |
| Length | 900 mm | 745 mm | 760 mm |
| Tubing | Single lumen with rounded, open<br>distal end | Single lumen with rounded, closed<br>distal end | Single lumen with rounded, closed<br>distal end |
| Distal side holes | Yes | Yes | Yes |
| Balloon and Inflation<br>Valve | Yes | Yes | No |
| Balloon Position | Side of the distal end | 6.8 cm from the distal end | NA |
| Markings | Every 5 cm, from 15 to 70 cm from<br>the distal end of the tube | Markings are provided with the zero<br>reference located approximately 39.6<br>cm from the proximal end of the<br>balloon | Blue marking 30 – 40 – 50cm from the<br>distal end of the tube |
| | | Materials | |
| Tubing Material | Silicone | Silicone | Styrene-Ethylene-Butylene-Styrene<br>(SEBS Co-polymer) |
| | | Biological characteristics | |
| Sterility | Supplied sterile, disposable, single<br>patient use | Supplied non-sterile, disposable,<br>single patient use | Supplied non-sterile, disposable,<br>single patient use |
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Image /page/7/Picture/0 description: The image shows the logo for Medical Innovation Developpement. The logo is blue and features the letters "MiD" in a stylized font. The letters are connected by a curved line that forms a circle around the "D". To the right of the letters, the words "MEDICAL INNOVATION DEVELOPPEMENT" are stacked vertically in a smaller font.
- 2.2 Discussion
#### 2.2.1 Intended use
The indications for use statement for the proposed device contain language that is not specifically incorporated in the indications for use statements of the predicate devices. The proposed device indications for use statement include "calibration". While the exact text "calibration" is not specifically included in the indications for use statements of the predicate devices, it refers to the terms "size", "sizing", "provide visible and tactile delineation of the stomach", and "size a gastric pouch".
The indications for use statement of the proposed device contain the text "Sleeve Gastrectomy" whereas it is not specifically stated in the indications for use statements of the predicate devices. It is included in the procedures referred to as "gastric and bariatric surgical procedures" in the indications for use statements of the predicate devices. The three devices are intended to perform the same functions: suction, drainage, sizing and irrigation.
The range of surgical applications and the patient population defined for the proposed device are not as wide as the ones defined for the predicate devices. However, all surgical applications for the MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy are within the range of surgical applications as defined by the predicate devices and do not affect the safety or performance of the device.
#### 2.2.2 Technical Characteristics
Many similarities can be observed in the intended use of the three devices, including their main design characteristics and their general indications for use. However, differences concerning sterility, the tube and the balloon were identified.
Whereas the proposed device is supplied EO-sterilized, its predicate devices are supplied nonsterile. The proposed device is safer when it comes to infection risks and any additional risk of residual ethylene oxide intoxication is limited by the use of a validated aeration method (see section 14).
The tubes of the three devices differ slightly in their dimensions, materials and the features they include. As they allow the same calibration of a gastric pouch to be performed and do not make the tube handling more difficult, the differences of length and outer diameter do not impair the safety and performance of the device. Differences from the predicate devices which may exist concerning the materials used in the proposed device raise no safety concern since the biocompatibility of these materials was assessed (see section 15). Specificities concerning the features of the proposed device, such as the presence of a colored orientation band, the format and spatial distribution of the markings and the absence of suction connector do not impair its safety and performance and only improve the ease of use as compared to the predicate device.
The presence of a balloon on the proposed device allows calibration to be achieved. Its specific position on the tube does not impact this function as compared to the REALIZE™ Gastric Calibration Tube. No additional risk is implied and the main principles of operation of the device are not impacted.
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The differences discussed above do not affect the safety and effectiveness of the new device when used as labeled.
#### 2.2.3 Performance testing
The MIDSLEEVE™, Calibration tube for Sleeve gastrectomy conforms to:
ISO 11607-01:2009, Packaging for terminally sterilized medical devices - Part 1: . Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-01:2009, Packaging for terminally sterilized medical devices – Part 2: Validation . requirements for forming, sealing and assembly processes
. ASTM F88-09:2009, Standard test Method for Seal Strength of Flexible Barrier Materials
ASTM F1980-07:2011, Standard Guide for Accelerated Aging of Sterile Barrier Systems for . Medical Devices
NF EN ISO 10993-1:2010 : Biological evaluation of medical devices - Part 1: Evaluation . and testing within a risk management process
ASTM F1140/F1140M-13: Standard Test Methods for Internal Pressurization Failure . Resistance of Unrestrained Packages
NF EN ISO 10993-5:2010: Biological evaluation of medical devices -- Part 5: Tests for In ● Vitro cytotoxicity
NF EN ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for . irritation and skin sensitization
The MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy conforms engineering specifications for usability and reliability:
- 0 Dimensional Analysis
- 0 Reliability and Safety of the Distal Balloon Inflation and Proximal Valve
- Burst Volume Testing on the Inflated Balloon 0
- 0 Distal End piece Gluing Reliability
- o Valve to Tube Joint Strength Test
- . Sterile Packaging Integrity
The performance testing conducted with the MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy referenced above indicates the new device performs equivalently to, or better than the predicate devices.
### 3. Conclusion
As evidenced from the similarities and the differences discussed above and from the intended use, technological characteristics and performance testing conducted, the MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is as safe, as effective and performs as well as the predicate devices.
