(29 days)
Not Found
No
The summary describes a physical, flexible gastric tube used for mechanical functions (decompression, drainage, sizing) and provides tactile/visible delineation. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device's stated indications for use are primarily diagnostic and supportive during surgical procedures (decompressing, draining, removing fluid, irrigating, sizing guide) rather than directly treating a medical condition or restoring function.
No
Explanation: The device is used to decompress, drain, irrigate, and act as a sizing guide during gastric surgical procedures. It does not provide diagnostic information such as identifying diseases or conditions.
No
The device description clearly states it is a flexible gastric tube, which is a physical hardware component.
Based on the provided information, the ReShape Calibration Tubes™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- ReShape Calibration Tubes™ Function: The description clearly states the device is a flexible gastric tube used during surgical procedures. Its functions are to decompress the stomach, drain/remove fluid, irrigate, and act as a sizing guide. These are all actions performed within the body during surgery, not on specimens outside the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, the ReShape Calibration Tubes™ falls under the category of a surgical instrument or device used directly on the patient during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
ReShape Calibration Tubes™ are indicated for use in gastric surgical procedures to decompress the stomach. drain and remove gastric fluid, irrigate, and act as a sizing guide.
Product codes
KNT
Device Description
The ReShape Calibration Tubes™ is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures and is available in three larger sizes. The trade name has been changed Gastrointestinal Boundary Identifier (GIBI HD ™) to ReShape Calibration Tubes ™ for these three (3) sizes.
The ReShape Calibration Tubes™ provide visible and tactile delineation of the gastroesophageal (GE) junction, and its location relative to the esophageal hiatus and antrum of the stomach. The device provides the ability to decompress the stomach, drain and remove gastric fluid and act as a sizing guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric, gastroesophageal (GE) junction, esophageal hiatus, antrum of the stomach
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)
Bench testing was not conducted and remains same as the predicate device cleared under K221898.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2023
ReShape Lifesciences Dov Gal VP of Regulatory, Quality, & Clinical 1001 Calle Amanecer San Clemente, CA 92673
Re: K230131
Trade/Device Name: ReShape Calibration Tubes Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: January 16, 2023 Received: January 17, 2023
Dear Dov Gal:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Je An -S" in black font. The text is arranged horizontally, with "Je" on the left, "An" in the middle, and "-S" on the right. There is a faint, light blue watermark in the background that is difficult to discern.
Je Hi An, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name ReShape Calibration TubesTM
Indications for Use (Describe)
ReShape Calibration Tubes™ are indicated for use in gastric surgical procedures to decompress the stomach. drain and remove gastric fluid, irrigate, and act as a sizing guide.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
Confidential
3
Image /page/3/Picture/0 description: The image contains the logo for ReShape Lifesciences. The logo features a stylized orange circle that is not fully complete. The text "ReShape" is written in a combination of orange and purple, with "Re" in orange and "Shape" in purple. Below "ReShape" is the word "Lifesciences" in purple.
510(k) Summary
I. Basic Information
| 510(k) Owner | ReShape Lifesciences
1001 Calle Amanecer
San Clemente CA 92673
Phone: (844) 937-7374
Establishment Registration No: 3013508647 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Dov Gal, VP of Regulatory, Quality, & Clinical |
| Date of summary | January 16, 2023 |
| Trade Name | The ReShape Calibration Tubes™ |
| Common Name | Introduction/Drainage Catheter |
| Classification | Class II, KNT |
| Classification Name | Gastrointestinal Tube and Accessories |
| Predicate Device | ReShape Lifesciences Gastrointestinal Boundary Identifier (GIBI HD ™)
Calibration Tube, K221898 |
II. DEVICE DESCRIPTION
The subject device is the same as the Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube, which is also manufactured by our company, ReShape Lifesciences Inc., and was cleared under 510(k) K221898. The reason for the submission is the addition of a contraindication to the Directions for Use (DFU). Other changes described in this submission are the device name and minor edits to the DFU.
The ReShape Calibration Tubes™ is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures and is available in three larger sizes. The trade name has been changed Gastrointestinal Boundary Identifier (GIBI HD ™) to ReShape Calibration Tubes ™ for these three (3) sizes.
The ReShape Calibration Tubes™ provide visible and tactile delineation of the gastroesophageal (GE) junction, and its location relative to the esophageal hiatus and antrum of the stomach. The device provides the ability to decompress the stomach, drain and remove gastric fluid and act as a sizing guide (Figure 1).
4
Image /page/4/Picture/1 description: The image shows a clear, flexible tube, likely a medical device such as a feeding tube or catheter. The tube is coiled and has a blue clamp attached to it. One end of the tube has a bulbous tip with multiple holes, while the other end has a connector with a cap.
Figure 1: ReShape Calibration Tubes™ (Representative figure of all Models: B-2032, B-2040)
III. INDICATIONS FOR USE
ReShape Calibration Tubes™ are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
IV. BASIS FOR SUBSTANTIAL EQUIVALENCE
Substantial equivalence of the ReShape Calibration Tubes™ to the predicate device (ReShape Lifesciences Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube, K221898) was already established through an evaluation of the indications for use, principle of operation, device design, materials of construction, and an assessment of usability, safety, and effectiveness via bench studies.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. THE PREDICATE DEVICE
A comparison of the ReShape Calibration Tubes and the predicate device is provided in Table 1.
| Feature | Predicate Device
ReShape Lifesciences Gastrointestinal
Boundary Identifier (GIBI HD ™) Calibration
Tube, K221898 | Subject Device
ReShape Calibration Tubes | Effect on
Substantial
Equivalence |
|-------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------|
| Product Code | KNT | Same | None |
| Regulatory Class | Class II | Same | None |
| Regulation Number | 21 C.F.R. 876.5980 | Same | None |
| Regulation Name | Gastroenterology-Urology | Same | None |
| Table 1: Comparison of Subject Device and Predicate Device | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------ |
5
| Feature | Predicate Device
ReShape Lifesciences Gastrointestinal
Boundary Identifier (GIBI HD ™) Calibration
Tube, K221898 | Subject Device
ReShape Calibration Tubes | Effect on
Substantial
Equivalence |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Indications for Use | The GIBI HD™ is indicated for use in
gastric and bariatric surgical
procedures to decompress the
stomach, drain and remove gastric
fluid, irrigate, and act as a sizing
guide. | ReShape Calibration Tubes™
are indicated for use in
gastric and bariatric surgical
procedures to decompress
the stomach, drain and
remove gastric fluid, irrigate,
and act as a sizing guide. | None |
| Outer Diameter /
French Size nominal | B-2032 : 32F
B-2036 : 36FB-2040: 40F | Same | None |
| Outer Diameter /
French Size distal tip | B-2032 : 38F
B-2036 : 42F
B-2040 : 42F | Same | None |
| Outer Diameter /
French Size deflated
balloon | B-2032 : 50F
B-2036 : 52FB-2040: 56F | Same | None |
| Tubing | Dual lumen | Same | None |
| Distal Side Holes | 3 aspiration holes proximal to the
balloon to ensure a steady vacuum | Same | None |
| Distal Tip | Molded tip with twelve (12)
aspiration eyelets. | Same | No impact to
substantial
equivalence. |
| Connector for
Suction | The catheter includes an adapter
for room suction | Same | None |
| Balloon + Inflation
Valve | The balloon has an inflation
capacity ≥ 100 cc min. | Same | None |
| Tubing Material | Silicone | Same | None |
| Markings | Indication marks at 30, 35, 40, 45,
and 50, 55, and 60 centimeters. | Same | None |
| Sterility | Non-sterile, disposable, single
patient use | Same | None |
| Shelf Life | 2 years | Same | None. |
6
VI. PERFORMANCE DATA
Bench testing was not conducted and remains same as the predicate device cleared under K221898.
VII. CONCLUSION
Data presented in this submission demonstrate that the updated DFU is similar and equivalent to of the ReShape Gastrointestinal Boundary Identifier (GIBI HD) Calibration tube (K221898).
The ReShape Calibration Tubes™ device, and the predicate device (Gastrointestinal Boundary Identifier
(GIBI HD) Calibration tube):
- have the same intended use,
- · use the same principle of operation,
- · incorporate the same design,
- have the same construction and material, and
- are both provided non-sterile.
In summary, the ReShape Calibration Tubes™ device described in this submission is substantially equivalent to the predicate device, the Gastrointestinal Boundary Identifier (GIBI HD) Calibration tube (K221898).