(26 days)
Not Found
No
The description focuses on the mechanical function of a specimen retrieval bag and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used to retrieve tissue specimens during surgery, not to treat a disease or condition.
No
Explanation: The device is described as a "Specimen Retrieval Bag" used to "capture organs or tissue to be removed from the body cavity" during laparoscopic procedures. Its function is to collect and extract tissue specimens, not to diagnose conditions.
No
The device description clearly outlines physical components such as a flexible plastic bag, spring finger, deployment shaft, shaft handle, and insertion tube, indicating it is a hardware device.
Based on the provided information, the ENDOCOLLECT Specimen Retrieval Bag is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture organs or tissue to be removed from the body cavity" during laparoscopic procedures. This is a surgical device used in vivo (within the body) for specimen collection, not for testing or analyzing samples in vitro (outside the body).
- Device Description: The description details a physical device for collecting and extracting tissue specimens during surgery. It doesn't mention any components or functions related to diagnostic testing of the collected tissue.
- Lack of Diagnostic Information: The document does not mention any diagnostic purpose, analysis of biological samples, or any metrics related to diagnostic performance (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The ENDOCOLLECT is a tool for collecting the specimen, not for performing the diagnostic test on it.
N/A
Intended Use / Indications for Use
The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
Product codes
GCJ
Device Description
The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavity
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
All necessary performance testing was conducted on the ENDOCOLLECT Specimen Retrieval Bag to support a determination of substantial equivalence to the predicate device.
Testing included:
- · Nonclinical Bench Testing
- o Force and Volume Testing
- o Durability Testing
- o Puncture Testing
- o Spring Finger Deflection Testing
- o Weight Capacity and Air Leak Testing
- · Sterilization Validation
- · Shelf-Life Testing
- · Transportation Testing
- · Usability Validation Testing
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ENDOCOLLECT Specimen Retrieval Bag meet the established specifications necessary for consistent performance during its intended use. In addition, the results of the performance that the differences in technological characteristics between the ENDOCOLLECT Specimen Retrieval Bag do not raise different questions of safety and effectiveness when compared to the predicate device.
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
Nonclinical performance testing has been performed on the modified devices to evaluate the overall performance. The collective results confirm that the modified devices meet its specifications and requirements for its intended use. The modified ENDCOLLECT Specimen Retrieval Bag is substantially equivalent to the predicate device.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
April 1, 2024
Ximedica % Valerie Defiesta-Ng Vice President Regulatory Affairs Veranex, Inc. 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K240635
Trade/Device Name: ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 6, 2024 Received: March 6, 2024
Dear Valerie Defiesta-Ng:
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.
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"
1
(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 OS 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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2024.04.01
13:47:37 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
ENDOCOLLECT Specimen Retrieval Bag, 8mm; ENDOCOLLECT Specimen Retrieval Bag, 12mm; ENDOCOLLECT Specimen Retrieval Bag, 15mm
Indications for Use (Describe)
The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
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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Page 1 of 1
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K240635 Page 1 of 2
510(k) Summary Prepared on: 2024-03-05
| 510(k) #: | |
|---|---|
| ----------- | -- |
Contact Details 21 CFR 807.92(a)(1)
| Applicant Name | Ximedica |
|---|---|
| Applicant Address | 55 Dupont Drive Providence RI 02907 United States |
| Applicant Contact Telephone | 401-330-5956 |
| Applicant Contact | Ms. Corie Vazquez |
| Applicant Contact Email | corie.vazquez@veranex.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | ENDOCOLLECT Specimen Retrieval Bag, 8mm; ENDOCOLLECT Specimen Retrieval Bag, 12mm; ENDOCOLLECT Specimen Retrieval Bag, 15mm |
|---|---|
| Common Name | Endoscope and accessories |
| Classification Name | Laparoscope |
| Regulation Number | 876.1500 |
| Product Code(s) | GCJ |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K232519 | ENDOCOLLECT Specimen Retrieval Bag | GCJ |
Device Description Summary 21 CFR 807.92(a)(4)
The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
Indications for Use Comparison 21 CFR 807.92(a)(5)
The indications for use of the proposed device are the same as the predicate device.
Technological Comparison 21 CFR 807.92(a)(6)
5
K240635
The modifications outlined in this Special 510(k) premarket notification do not raise different questions of safety or effectiveness as demonstrated by performance testing using the same methods that were utilized for the predicate device. Furthermore, these changes (1) do not affect the intended use or (2) alter the fundamental scientific technology of the device. The modified devices retain the same core technological characteristics as the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
All necessary performance testing was conducted on the ENDOCOLLECT Specimen Retrieval Bag to support a determination of substantial equivalence to the predicate device.
Testing included:
- · Nonclinical Bench Testing
- o Force and Volume Testing
- o Durability Testing
- o Puncture Testing
- o Spring Finger Deflection Testing
- o Weight Capacity and Air Leak Testing
- · Sterilization Validation
- · Shelf-Life Testing
- · Transportation Testing
- · Usability Validation Testing
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ENDOCOLLECT Specimen Retrieval Bag meet the established specifications necessary for consistent performance during its intended use. In addition, the results of the performance that the differences in technological characteristics between the ENDOCOLLECT Specimen Retrieval Bag do not raise different questions of safety and effectiveness when compared to the predicate device.
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
Nonclinical performance testing has been performed on the modified devices to evaluate the overall performance. The collective results confirm that the modified devices meet its specifications and requirements for its intended use. The modified ENDCOLLECT Specimen Retrieval Bag is substantially equivalent to the predicate device.