(30 days)
No
The device description and performance studies focus on the physical characteristics and biocompatibility of flexible gastric tubes, with no mention of AI or ML technologies.
No
The devices are surgical tools for sizing, fluid removal, and decompression during gastric procedures, not for treating a disease or condition itself.
No
The device is used for surgical procedures to decompress, drain, irrigate, and act as a sizing guide, not to diagnose a medical condition.
No
The device description clearly states that the devices are "flexible gastric tubes" and "catheters," which are physical hardware components used in surgical procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures to decompress, drain, irrigate, and act as a sizing guide within the stomach. This is a direct interaction with the patient's body during a procedure.
- Device Description: The device is a flexible gastric tube used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo during a surgical procedure.
N/A
Intended Use / 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.
The Gastric Balloon Suction Catheter is 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 (comma separated list FDA assigned to the subject device)
KNT
Device Description
The ReShape Calibration Tubes™ (Model B-2032, B-2040, and B-2017) and the Gastric Balloon Suction Catheter (Model B-2020) are manufactured by our company, ReShape Lifesciences. These catheters are flexible gastric tubes designed to be used in gastric and bariatic surgical procedures. The catheters provide visible and tactie delineation of the gastroesophageal (GE) junction and its location relative to the esophageal hiatus and antrum of the stomach. These devices provide the ability to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide. Models B-2032, B-2040 were previously cleared under K230123. Model B-2017 was previously named Lap-Band System Calibration Tube and cleared under K220455. Model B-2020 was previously cleared under K002838. There are no changes to the principle of operation or technological characteristics of the devices.
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)
The final finished subject devices with the proposed design modification have been tested in accordance with applicable ISO 10993 standards and in compliance with 21 CFR Part 58, and concluded non-cytotoxic, non-sensitizing, and non-irritant. The labeled shelf life of 7 years is supported by leveraging the shelf life data of Model B-2017 previously cleared under K220455 with appropriate rationale. No bench testing, packaging study, usability study, or sterility are deemed applicable or necessary for these with proposed modifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
non-cytotoxic, non-sensitizing, and non-irritant
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.
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 16, 2024
ReShape Lifesciences Eva Chang Senior Director of Regulatory Affairs 18 Technology Drive Suite 110 Irvine, California 92618
Re: K241039
Trade/Device Name: ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: April 16, 2024 Received: April 16, 2024
Dear Eva Chang:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Anthony Lee -S
Anthony C. Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity
2
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
3
Indications for Use
Submission Number (if known)
Device Name
ReShape Calibration Tubes (B-2032, B-2036, B-2040);
ReShape Calibration Tubes (B-2017);
Gastric Balloon Suction Catheter (B-2020)
Indications for Use (Describe)
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.
The Gastric Balloon Suction Catheter is 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K241039 Page 1 of 2
510(k) Summary
Prepared on: 2024-04-16
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | ReShape Lifesciences | |
| Applicant Address | 18 Technology Drive Suite 110 Irvine CA 92618 United States | |
| Applicant Contact Telephone | 949-245-1174 | |
| Applicant Contact | Ms. Eva (Ming Yi) Chang | |
| Applicant Contact Email | echang@reshapelifesci.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | ReShape Calibration Tubes (B-2032, B-2036, B-2040); | |
| ReShape Calibration Tubes (B-2017); | ||
| Gastric Balloon Suction Catheter (B-2020) | ||
| Common Name | Gastrointestinal tube and accessories | |
| Classification Name | Tubes, Gastrointestinal (And Accessories) | |
| Regulation Number | 876.5980 | |
| Product Code(s) | KNT | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
Device Description Summary
The ReShape Calibration Tubes™ (Model B-2032, B-2040, and B-2017) and the Gastric Balloon Suction Catheter (Model B-2020) are manufactured by our company, ReShape Lifesciences. These catheters are flexible gastric tubes designed to be used in gastric and bariatic surgical procedures. The catheters provide visible and tactie delineation of the gastroesophageal (GE) junction and its location relative to the esophageal hiatus and antrum of the stomach. These devices provide the ability to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide. Models B-2032, B-2040 were previously cleared under K230123. Model B-2017 was previously named Lap-Band System Calibration Tube and cleared under K220455. Model B-2020 was previously cleared under K002838. There are no changes to the principle of operation or technological characteristics of the devices.
Lap-Band System Calibration Tube
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 quide.
The Gastric Balloon Suction Catheted for use in gastric and bariatic surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
KNT
21 CFR 807.92(a)(4)
The subject devices have the same intended use as the predicate device. The indications for use statement do not alter the indications or intended use .
5
Technological Comparison
Page 2 of 2 21 CFR 807.92(a)(6)
The subject devices, ReShape Calibration Tubes (Models B-2017, B-2032, B-2040) and the Gastric Balloon Suction Catheter (Model B-2020), are substantially equivalent to the predicate device Lap-Band System Calibration Tube (Model B-2017) cleared to market June 7, 2022 (K220455), with respect to the indications for use, designs, and fundamental technological and performance characteristics. The minor differences between the predicate devices include the material change to the black length marking ink/paste printed on the outer shaft of the catheters. Other minor labeling updates include product name change, the addition of a general contraindication, and labeled shelf life, which have no impact on the substantial equivalence.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The final finished subject devices with the proposed design modification have been tested in accordance with applicable ISO 10993 standards and in compliance with 21 CFR Part 58, and concluded non-cytotoxic, non-sensitizing, and non-irritant. The labeled shelf life of 7 years is supported by leveraging the shelf life data of Model B-2017 previously cleared under K220455 with appropriate rationale. No bench testing, packaging study, usability study, or sterility are deemed applicable or necessary for these with proposed modifications.