(49 days)
Not Found
No
The device description focuses on mechanical components, visualization, and surgical tools. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making capabilities.
No
This device is used for the surgical cutting and removal of tissues (ligaments, tendons, fascia) in procedures like Plantar Fasciotomy and Carpal Tunnel Release, which are interventions to treat conditions, not to provide therapy.
No
The device is described as a "Tunnel Release Device" used for "recession/incision of ligament, tendons, or fascia." Its primary function is a surgical procedure to cut or release tissue, not to diagnose a condition. While it uses an endoscope for visualization during the procedure, visualization in this context is for guiding the surgical tool, not for making a diagnosis.
No
The device description clearly outlines physical components including a hand piece, tissue cutting probe, endoscope camera, fiber optic illumination system, and surgical blades. These are hardware components, not software.
Based on the provided information, the Socorro SMI Tunnel Release Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use of the Socorro SMI Tunnel Release Device is for the minimally invasive examination, isolation, and recession/incision of tissues within the body (ligaments, tendons, fascia).
- The device is a surgical instrument. It is used to perform a surgical procedure (cutting tissue) directly on the patient.
- The input imaging modality is an endoscope camera. This is used for visualization during the surgical procedure, not for analyzing a specimen.
Therefore, the Socorro SMI Tunnel Release Device is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy, -Carpal Tunnel Release, -Elbow Cubital Tunnel Release and -Gastrocnemius Tenotomy.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, EMF
Device Description
The SMI Tunnel Release Device is comprised of a hand piece with a tissue cutting probe which is used in conjunction with an endoscope camera and fiber optic illumination system. The device is supplied sterile and is for single use only.
The hand piece provides an actuation member for extending, retracting, and angularly rotating surgical blades which are attached to the distal end of the hand piece. Basic features of these probes are a retraction region and visualization that is nearly threehundred and sixty degrees (360°).
The visualization scope connects with the camera head and optic cables which provide the surgeon a clear and complete view of the surgical site on the overhead monitor.
The endoscope is used to illuminate and visualize the anatomy in or around the operative site. It allows the physician to directly visualize the actions of the probe during the procedure and to verify complete excision of the targeted tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, elbow, knee, ankle or heel
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 has demonstrated that the device is in compliance with international standards, the expectations of the medical community and the product labeling.
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.
0
Section 5: 510(k) Summary
K102219 SEP 2 4 2010
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Socorro Medical, Inc. |
| 450 Sutter Street, Suite 500 | |
| San Francisco, CA 94108 | |
| Contact: Ed Diao, M.D. | |
| ediao@sf-sc.com | |
| 415-362-8880 | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Surgical Knife |
| Device Classification & Code: | Class II (due to specific claims, otherwise Class I), |
| EMF | |
| Device Classification Name: | 21 CFR 878.4800 |
Socorro SMI Tunnel Release Device
Predicate Device Information:
Device Proprietary Name:
| Predicate Device: | A.M. Surgical Mountable Endoscopic Blade |
|---|---|
| Predicate Device Manufacturer: | A.M. Surgical, Inc. |
| Predicate Device Common Name: | Surgical Knife |
| Predicate Device Classification: | 21 CFR 878.4800 |
| Predicate Device Classification & Code: | Class II, EMF |
| Premarket Notification Number: | K080133 |
b. Date Summary Prepared
18 June 2010
c. Description of Device
The SMI Tunnel Release Device is comprised of a hand piece with a tissue cutting probe which is used in conjunction with an endoscope camera and fiber optic illumination system. The device is supplied sterile and is for single use only.
The hand piece provides an actuation member for extending, retracting, and angularly rotating surgical blades which are attached to the distal end of the hand piece. Basic features of these probes are a retraction region and visualization that is nearly threehundred and sixty degrees (360°).
The visualization scope connects with the camera head and optic cables which provide the surgeon a clear and complete view of the surgical site on the overhead monitor.
1
Image /page/1/Picture/0 description: The image shows a logo with the word "SOCORRO" written in a sans-serif font. Above the word is a circular graphic that appears to be a stylized representation of a celestial body, possibly a moon or planet, with craters or surface details visible. The text below "SOCORRO" is illegible due to the image's resolution.
The endoscope is used to illuminate and visualize the anatomy in or around the operative site. It allows the physician to directly visualize the actions of the probe during the procedure and to verify complete excision of the targeted tissue.
d. Intended Use
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy, -Carpal Tunnel Release, -Elbow Cubital Tunnel Release and -Gastrocnemius Tenotomy.
e. Comparison to Predicate Device
The Socorro SMI Tunnel Release Device is substantially equivalent in intended use, technology, design and materials to the A.M. Surgical Mountable Endoscopic Blade (K080133).
The Socorro SMI Tunnel Release Device and its predicate all provide technology to access and relieve an entrapment neuropathy that occurs when a nerve or tendon at the wrist, elbow, knee, ankle or heel is compressed by a thickened tendon sheath, edema or soft-tissue mass. An endoscope is guided into the joint through a small incision(s) above and/or below the affected joint. Small cutting tools (mechanical blades) are then used to excise the tendon sheath or mass under direct observation.
The patient contacting components that make up the application device and its predicate is stainless steel. The blades are provided sterile and are for single use only. Other components of the predicate device are sterilized between uses while the entire application device is provided sterile and is for single use only.
The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.
Socorro Medical concludes that the devices are substantially equivalent.
f. Summary of Supporting Data
Bench testing has demonstrated that the device is in compliance with international standards, the expectations of the medical community and the product labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Socorro Medical, Inc. % Coombs Medical Device Consulting Mr. Craig Coombs 1193 Sherman Street Alameda, California 94501
SEP 2 4 2010
Re: K102219
Trade/Device Name: Socorro SMI Tunnel Release Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, EMF Dated: September 20, 2010 Received: September 22, 2010
Dear Mr. Coombs:
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
3
Page 2 - Mr. Craig Coombs
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
510(k) Number (if known):
K102277
SEP 24 2010
Device Name: Socorro SMI Tunnel Release Device
Indications For Use:
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy,
-Carpal Tunnel Release,
-Elbow Cubital Tunnel Release and
- -Gastrocnemius Tenotomy.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Neil R. Doyle for nxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K|02219